Vertebral access system and methods

ABSTRACT

Medical devices, medical procedure trays, kits and related methods are provided for use to perform medical procedures that require access to the interior of a bone. The devices, trays and methods allow multiple use of non-sterile medical devices with sterile medical devices for performing medical procedures requiring sterile conditions.

RELATED APPLICATIONS

This application claims priority under 35 U.S.C. 120 to U.S. patentapplication Ser. No. 12/407,651, filed Mar. 19, 2009, which is acontinuation-in-part application of U.S. patent application Ser. No.11/853,701, filed Sep. 11, 2007, which claims the benefit of U.S.Provisional Patent Application Ser. No. 60/825,325 entitled “Apparatusand Methods for Biopsy and Aspiration of Bone Marrow” filed Sep. 12,2006, and claims the benefit of U.S. Provisional Patent Application Ser.No. 60/910,122 entitled “Powered Driver Intraosseous Device and MethodsTo Access Bone Marrow” filed Apr. 4, 2007. The contents of theseapplications are incorporated herein in their entirety by thisreference.

TECHNICAL FIELD

The present disclosure is related generally to non-surgical medicalprocedures such as diagnosis, evaluation and treatment of bones,including factures, vertebral fractures, and/or other disease or injuryto a patient's spine and to medical devices associated with suchprocedures. The disclosure also relates to medical procedure trays andkits for use in conjunction with diagnostic and therapeutic medicalprocedures for bone related disorders.

BACKGROUND OF THE DISCLOSURE

There are many clinical conditions that require access to bone tissues,such as bone marrow. In some cases it is important to access andretrieve bone tissue and/or bone marrow for diagnosis or treatment ofconditions such as but not limited to, osteoporosis, degenerative bonediseases, fractures, vertebral fractures, cancers of any type andhematologic disease of any origin. For example, it may be necessary toaccess bone tissues and/or bone marrow to obtain a sample or specimenfor diagnostic testing.

In other cases it may be necessary to introduce a medicament or atherapeutic agent directly into bone tissue or bone marrow that may beuseful to treat or ameliorate a clinical condition. For example, it maybe necessary to treat diseases with bone marrow or stem cell transplantsto restore functioning blood cells. Such conditions may include, but arenot limited to, acute leukemia, brain tumors, breast cancer, Hodgkin'sdisease, multiple myeloma, neuroblastoma, non-Hodgkin's lymphomas,ovarian cancer, sarcoma and testicular cancer. In other cases, it may benecessary to treat conditions such as osteoporosis, degenerative bonedisorders, or fractures by introducing a medicament into the bone orbone marrow.

Gaining access to bone and associated bone marrow for a small biopsyspecimen and/or aspiration of a larger quantity of bone marrow and/or tointroduce a medicament may be difficult, traumatic and occasionallydangerous, depending on each selected target area for harvesting boneand/or associated bone marrow, operator expertise and patient. Currentlyavailable devices and techniques for gaining access to a bone andassociated bone marrow may include an intraosseous (IO) needle with aremovable trocar disposed therein. Various shapes and sizes of handlesmay be used to apply manual pressure and to manually rotate the IOneedle and removable trocar as a set. Such manual IO devices oftenrequire substantial force to break through the outer cortex of a bone.Exertion of such force may cause pain to a patient and may sometimesdamage the bone and/or IO device. Such force may especially cause damagewhen harvesting bone marrow from children with softer bone structures orfrom any patient with bones deteriorated by disease (osteoporosis,cancer, fractures).

Occasionally a core specimen of bone and/or bone marrow may not besuccessfully retrieved using a standard biopsy needle. Thus, multipleinsertions at different sites may be necessary to obtain a satisfactorybone and/or bone marrow biopsy specimen. Risks to health care personnelmay be higher because of increased handling of blood contaminated sharpinstruments. Accidental needle sticks and missed target areas mayfurther complicate procedures and increase risks to health carepersonnel and/or patients.

Conventional bone marrow transplant techniques may require multiplepenetration sites (up to 20 per patient) in order to obtain enough bonemarrow to perform a routine bone marrow transplant. This procedure isoften labor intensive. Conventional biopsy needles and/or aspirationneedles are typically inserted with considerable manual force. Thisforce may cause loss of control or operator fatigue. When the biopsyneedle or aspiration needle is in place, an associated trocar isgenerally removed and a syringe attached to one end of the needle toaspirate a few cubic centimeters of bone marrow. The biopsy oraspiration needle is then withdrawn. A new insertion site may bepenetrated, often about a centimeter from the first insertion site. Theprocedure may be repeated multiple times. There is a need for betterapparatus and methods for accessing bone tissue.

Vertebroplasty may often be performed with a patient sedated but awake,in a x-ray suite or an operating room. During vertebroplasty, a bonecement is typically injected under pressure directly into a fracturedvertebra. Once in position, the cement may harden in about ten minutesor less, depending upon the type of cement, congealing the fragments ofthe fractured vertebra and providing immediate stability.

SUMMARY OF THE DISCLOSURE

In accordance with the teachings of the present disclosure, apparatus,devices, medical procedure trays, medical kits, and therapeutic anddiagnostic methods are provided for gaining access to bone tissue and/orfor vascular access through bone tissue. Access to bone tissue may beused for providing a medicament or a therapeutic agent to bone tissuesand/or to obtain clinical samples by techniques such as aspirationand/or biopsy of bone marrow. In some embodiments, the presentdisclosure provides methods, apparatus, medical procedure trays and kitsfor access to vertebral bones for therapeutic and diagnostic purposes.

One aspect of the present disclosure may include an intraosseous (IO)device such as an IO needle set and a coupler assembly, with anon-sterile driver (manual or power driven) operable to insert the IOdevice into a bone and/or associated bone marrow. The coupler assemblymay comprise one end operable to releasably attach to an IO device andanother end operable to releasably attach to a non-sterile driver. Useof a non-sterile driver may be facilitated by a containment bag orsterile glove that is comprised in the coupler assembly and is used toprevent direct contact of the non-sterile driver with sterile needlesand a patient during a medical procedure such as diagnostic evaluationand/or providing one or more therapeutic agents to bone. A non-steriledriver may be used repeatedly in conjunction with disposable sterile IOneedle sets and couplers.

One aspect of the present disclosure may include placing a powereddriver within a containment bag or sterile enclosure that may beattached to the first end of a coupler assembly, to provide isolationbetween the powered driver and an exterior environment and maintain afluid barrier with adjacent portions of driver housing. The containmentbag may be formed from relatively flexible, lightweight, clearplastic-type materials. The containment bag may comprise a flexible stayon one side that may be opened to slide in a powered driver. Thecontainment bag may further comprise a flap and an adhesive strip thatmay be used to seal in the powered driver prior to use, such that asterile person does not contact the non-sterile driver. The containmentbag may be attached to the coupler attachment by an adhesive such as hotglue. However, a wide variety of connecting mechanisms such as, portassemblies, connectors, receptacles, fittings, hubs, hub assemblies,latching mechanisms and/or other types of connecting devicesincorporating teachings of the present disclosure may be satisfactorilyused to attach a container bag with the coupler assembly.

The end of the coupler assembly at which a containment bag may beattached may be proximate a tortuous path. A tortuous path may be anon-linear path and may comprise sharp curves and/or sharp bends suchthat bacteria, viruses and/or other pathogens that may be present on anon-sterile powered driver cannot easily traverse to cause contaminationof a sterile IO device attached at the other end of the couplerassembly. A tortuous path may also prevent contamination by bodilyfluids that may contain pathogens of non-sterile and sterile componentsof medical devices and/or exposure of personnel performing the medicalprocedures of the disclosure to such contaminants.

A further aspect of the present disclosure may include a couplerassembly further operable to releasably engage an intraosseous devicewith portions of a drive shaft extending from one end of a powereddriver. The coupler assembly may allow the powered driver to rotate or“spin” an intraosseous device at an insertion site (power in). Thecoupler assembly may also allow the powered driver to rotate or “spin”an intraosseous device during removal from the insertion site (powerout). This feature of the present disclosure may also be referred to as“power in and power out.”

Connectors as set forth above may also be used to releasably engage thecoupler with a powered driver and/or the intraosseous device. In someembodiments, a coupler may comprise a spinner which may be used toreleasably attach an intraosseous device to the second end of thecoupler assembly.

IO devices and needle sets that may be attached to a coupler assemblymay include one or more of the following: IO needles/devices/systemsoperable to provide access to a bone; IO needles/devices/systemsoperable to provide one or more therapeutic agents to bone; IOneedles/devices/systems operable to access vertebral bones; IOneedles/devices/systems operable to obtain a sample of bone and/or bonemarrow such as a biopsy needle system or a bone marrow aspirationsystem. One or more types of IO needles/devices/systems may be operableto be releasably attached to the coupler assemblies of the disclosurebased in part by the application for which the devices, systems and/ormethods may be used for.

In some aspects, the present disclosure may include medical proceduretrays comprising one or more IO needle sets and/or other intraosseousdevices, a coupler assembly comprising a sterile containment bag, andoptionally comprising a non-sterile power driver.

In accordance with the teachings of the present disclosure, one or moretherapeutic agents may be delivered to a bone of a patient in needthereof A therapeutic agent delivered using the methods, devices,medical procedure trays, and/or medical kits of the disclosure may havedirect effects on bone tissue or bone marrow such as but not limited toinducing bone tissue regeneration, bone strengthening, bone growth,regeneration of bone marrow, growth inhibition of cancerous cells inbone or bone marrow or combinations thereof. Alternatively, therapeuticagents may be delivered via the bone, using the devices and methods ofthis disclosure, to the vasculature or other effector sites and maymediate their therapeutic effects at such other sites. Some non-limitingexemplary therapeutic agents that may have direct effects on bone tissueinclude bone/surgical cements, bone morphogenetic factors,cartilage-derived morphogenetic factors, osteogenic factors,differentiating factors, anti-resorption agents, hormones, growthhormones, nucleic acid constructs encoding one or more of such agents,or pharmaceutical chemicals.

One aspect of the present disclosure may include a therapeutic methodthat may comprise accessing bone, such as a fractured bone, by insertingan intraosseous needle or needle set into a bone using a non-steriledriver and coupler assembly where the intraosseous needle is operable todeliver a therapeutic agent, such as a surgical or bone cement, to thefractured bone; and delivering the therapeutic agent to the bone. Insome aspects, the one or more therapeutic agents may stabilize, and/orstrengthen, and/or regenerate and/or rebuild a fractured bone.

In an exemplary procedure, an intraosseous needle set may be used toinitially cut through bone using a powered driver and coupler assembly(power in). An intraosseous needle set may include a cannula having asingle lumen and a trocar or stylet operable to be slidably disposedwithin the lumen of the cannula. Various types of connections including,but not limited to, Luer lock connections may be used to releasablyengage a trocar within a cannula. After insertion of a cannula into thebone a trocar maybe filled with surgical cement and maybe slidablydisposed into the lumen of the cannula to inject or deliver the surgicalcement into the fractured bone. After the surgical cement is deliveredthe trocar may be slidably removed followed by withdrawal of the cannulausing the powered driver (power out).

Some non-limiting exemplary uses for methods, devices, and medicalprocedure trays of the present disclosure may include use during varioustypes of procedures for strengthening or repairing fractured bones,procedures for strengthening or repairing bones that are weakened (byosteoporosis, aging, degenerative bone diseases or cancer), forameliorating and/or relieving pain due to compression fractures (such asspinal compression fractures), vertebroplasty procedures to inject bonecements into spinal bones, procedures for the delivery of one or moretherapeutic agents to a bone, stem cell transplant procedures. Bones ofany kind, such as but not limited to, vertebral bones, neck bones,sternum, rib, clavicle, femoral, pelvic, wrist and the distal ends ofthe long bones may be accessed, evaluated and treated by the presentdevices and methods.

In some aspects, the present disclosure provides medical procedure trayscomprising intraosseous devices for use in vertebroplasty methods. Insome aspects, a medical procedures tray of the disclosure may becomprised of several smaller trays. For example, one tray may comprisean IO device/needle sets (e.g., designed to penetrate and deliver atherapeutic agent to bone); another tray may comprise anotherintraosseous device (e.g., designed to obtain a biological specimen frombone or designed to deliver another therapeutic agent); yet another traymay comprise a coupler assembly comprising a sterile containment bag.All these trays may be then packaged into one bigger tray. Typically allthe devices will be sterilized and packaged with appropriate steriletechniques. The tray may also optionally comprise a non-sterile powereddriver which may be packaged in a separate section of the tray orprovided separately with the tray.

A vertebral procedure tray may comprise an IO needle set designed topenetrate into vertebral bones and deliver at least one therapeuticagent into the vertebral bone. A vertebral needle set may include acannula having a lumen and a trocar or stylet operable to be slidablydisposed within the lumen of the cannula and/or a cutting tip. Thevertebral IO needles may be releasably attached to a first end of thecoupler assembly while the non-sterile power driver may be attached to asecond end of the coupler assembly.

As vertebral procedures require imaging, such as fluoroscopy imaging orx-ray imaging techniques, to position a vertebral needle at the correctinsertion site and/or to monitor the injection of bone cement into avertebral body, one aspect of the present disclosure relates tovertebral needles comprising a small hub for providing the leastobstruction to visually viewing the needle and bone. Some embodiments,relate to the designing small IO needle hubs that allow for a clear viewto an operator while performing a medical procedure as set forth in thepresent disclosure.

A vertebral/medical procedure tray as set forth above may also comprisea bone and/or bone marrow biopsy system, having a biopsy needle orbiopsy needle set that may be releasably attached to the first end ofthe coupler assembly. The biopsy needle set may include a trocaroperable to be slidably or releasably disposed within the lumen of thevertebral needle set cannula. A single helical thread may be provided atone end of a biopsy needle to enhance capture of a biopsy specimen byscrewing the single helical thread into associated cancellous bone tocapture a bone marrow specimen or bone marrow core. A mandrel may beused to wind the helical thread of a biopsy needle.

Another exemplary vertebral/medical procedure tray as set forth abovemay further comprise a bone marrow aspiration system having anaspiration needle set that may be releasably attached to the first endof a coupler assembly, operable to insert the aspiration needle set intoa bone and associated bone marrow. The aspiration needle set may includea cannula having a single lumen and a trocar or stylet operable to beslidably disposed within the lumen of the cannula. The aspiration needletrocar or stylet may also be introduced into the same cannula as theother IO device/needle set of the tray. A medical and/or vertebralprocedures tray may comprise an IO device and/or needle set fordelivering a therapeutic agent (e.g., a bone cement, a pharmaceutical)to a bone; and a coupler assembly as set forth above, and optionally abiopsy needle set and/or an IO aspiration needle set.

The aspiration system and/or biopsy system trays may comprise containersto store the aspiration/biopsy samples and may also comprise suitablecontainers for sharp disposal. Medical procedure trays comprisingaspiration systems and/or biopsy systems may be used in connection withdetection of various bone diseases, including bone degenerativediseases, osteoporosis, fractures, bone cancers, detection of spread ofmetastatic cancers, detection of spread of infections, and other bonediseases.

In some embodiments, a medical procedure tray comprising an aspirationtray and/or a biopsy tray in addition to another IO device tray may beused to insert an IO needle comprising a cannula into a bone to provideaccess to bone; releasably inserting a biopsy and/or aspiration styletor trocar to obtain a biological bone sample for analysis; releasablyinserting another IO needle trocar into the same cannula to deliver atherapeutic agent in to the bone. In some aspects of this disclosure, adiagnostic test may be performed at the same time as a therapeuticprocedure thereby reducing the need for multiple insertions of devicesinto bone and reducing trauma associated with such procedures.

Various teaching of the present disclosure may be used with other typesof intraosseous devices and other types of medical procedures outsidethe field of providing bone or vascular access for treatment of apatient. Examples of such procedures may include, but are not limitedto, placement of wires and screws associated with replacement of jointsand internal fixation of bone fractures and many other orthopedicprocedures. Teachings of the present disclosure may also be incorporatedinto various gastroenterology-urology biopsy devices and procedures.Therapeutic and diagnostic methods and devices of the disclosure may beused in both acute care and out-patient facilities.

Another aspect of the present disclosure may include a medical kit fordiagnosis, evaluation and/or treatment of bone. In some embodiments, thepresent disclosure provides a vertebroplasty kit comprising anintraosseous needle set operable to penetrate vertebral bones anddeliver surgical cement into the vertebral body. A kit of the disclosuremay also include a biopsy system and/or an aspiration system and forsimultaneously obtaining a biopsy and/or bone marrow sample of bone. Akit of the disclosure may comprise containers to store thebiopsy/aspiration samples. A biological bone sample may be obtained fromthe same site as the site of delivery of therapeutic agent (e.g. cement)or may be obtained from a different site or a different bone.

A kit of the disclosure may also include one or more sharps containers.A coupler assembly, operable to be releasably coupled to a powereddriver, the coupler assembly comprising a sterile container bag may beincluded. A coupler assembly may have a means disposed on a first end toreleasably attach a powered driver to the coupler assembly and may havean additional means on a second end to releasably attach one or moreintraosseous needles or biopsy needles to the coupler. A powered drivermay be optionally provided with a kit of the disclosure or the kit maybe usable with commercially available powered drivers. A kit mayoptionally comprise one or more surgical cements and/or therapeuticagents.

A further aspect of the present disclosure may include a biopsy kitalong with an intraosseous procedure kit (for example, vertebroplastykit), further having a biopsy needle and an ejector or ejector rodoperable to remove a bone and/or bone marrow specimen from a biopsyneedle. A funnel (sometimes referred to as an “ejector funnel”) may alsobe included within the biopsy kit. The funnel may accommodate insertionof the ejector into one end of the biopsy needle. The funnel may includea reduced inside diameter portion formed in accordance with teachings ofthe present disclosure. For some embodiments, interior portions of thefunnel may function as a “one way connector” which may allow the funnelto function as a sharps protector for one end of the biopsy needledisposed therein.

Each component of a kit of the disclosure may be packaged in one or morecontainers. In some embodiments, a kit may comprise one or morecomponents in a first container and/or one or more components in asecond container and so on. Several smaller containers may be comprisedin a bigger container. Each container or the entire set of containersmay be sealed by a paper or plastic covering.

Apparatus and methods incorporating teachings of the present disclosuremay: Reduced physical requirements to insert an IO device into bone andassociated bone marrow.

Better control of an IO device during insertion.

Increased speed to complete an IO procedure.

Reduced discomfort to patients.

Simple, intuitive systems and procedures for an operator.

Multiple use of a non-sterile powered driver.

Availability of components to perform one or more medical procedures atthe same time by providing components in a medical procedure tray and/orkit.

Kits with components for procedures such as vertebroplasty.

Kits that may further comprise components for biopsy and/or aspirationprocedures and/or diagnostic and/or other therapeutic procedures.

Reduced requirement for multiple medical procedures, multiple insertionsand multiple scheduling for patients.

This summary contains only a limited number of examples of variousembodiments and features of the present disclosure. Additional examplesof embodiments and features will be discussed in the DetailedDescription of the Disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete and thorough understanding of the present embodimentsand advantages thereof may be acquired by referring to the followingdescription taken in conjunction with the accompanying drawings, inwhich like reference numbers indicate like features, and wherein:

FIG. 1A is a schematic drawing showing a plan view of one example of amedical procedures tray comprising an intraosseous needle set and abiopsy needle set, each needle set disposed in a separate tray, and acoupler assembly operable to be releasably attached to each needle setand to a non-sterile medical device (e.g., a powered driver, notexpressly shown), the coupler assembly further attached to a sterilecontainer bag and disposed in another tray incorporating teachings ofthe present disclosure;

FIG. 1B is a schematic drawing showing a plan view of one example of amedical procedures tray comprising an intraosseous needle set enclosedin a tray and a coupler assembly operable to be releasably attached tothe needle set and to a powered driver (not shown), the coupler assemblyfurther attached to a sterile container bag incorporating teachings ofthe present disclosure;

FIG. 1C is a schematic drawing showing an isometric view of one exampleof a medical procedures tray comprising an intraosseous needle setdepicting details of the tray incorporating teachings of the presentdisclosure;

FIG. 1D is a schematic drawing showing an isometric view of one exampleof a medical procedures tray comprising an intraosseous biopsy needleset depicting details of the tray incorporating teachings of the presentdisclosure;

FIG. 1E is a schematic drawing in section with portions broken awayshowing one example funnel of a medical procedures tray incorporatingthe teachings of the present disclosure;

FIG. 2A is a schematic drawing showing an isometric view of one exampleof a medical procedure tray that may include an intraosseous needle setand/or a biopsy needle set enclosed, each optionally enclosed in aseparate tray, and a coupler assembly attached to a sterile containerbag disposed in another tray, the coupler operable to be releasablyattached to a powered driver (one example of a non-sterile medicaldevice) as depicted in accordance with teachings of the presentdisclosure;

FIG. 2B is a drawing of a medical procedures tray showing one example ofa sterile container bag with a non-sterile powered driver disposedtherein and the driver attached releasably to a sterile coupler assemblyin accordance with teachings of the present disclosure;

FIG. 3A is a schematic drawing showing an isometric view of a userattaching a non-sterile powered driver to a sterile coupler assemblyattached to a sterile container bag in accordance with teachings of thepresent disclosure;

FIG. 3B is a schematic drawing showing still another isometric view of auser raising a sterile container bag of FIG. 3A with a flap and adhesivestrip to enclose the non-sterile powered driver coupled with a sterilecoupler assembly in accordance with teachings of the present disclosure;

FIG. 3C is a schematic drawing showing an isometric view of anon-sterile powered driver enclosed in a sterile container bagcomprising a flap and an adhesive strip, wherein the powered driver isreleasably coupled with a sterile coupler assembly and is furtherreleasably attached to an intraosseous device assembly, in accordancewith teachings of the present disclosure;

FIG. 4A is a schematic drawing showing an exploded, isometric view of apowered driver, coupler assembly with a sterile bag and an intraosseousdevice incorporating teachings of the present disclosure;

FIG. 4B is a schematic drawing showing another exploded, isometric viewof the coupler assembly with the sterile bag of FIG. 4A incorporatingteachings of the present disclosure;

FIG. 4C is a schematic drawing showing one example of a powered driveroperable for use with intraosseous (IO) devices incorporating teachingsof the present disclosure;

FIG. 5A is a schematic drawing in section with portions broken awayshowing a coupler assembly such as in FIGS. 4A and 4B in a secondposition showing release of a powered driver from a receptacle disposedin the first end of the coupler assembly and showing attachment of asterile containment bag and a tortuous path disposed proximateattachment site of containment bag, incorporating the teachings of thepresent disclosure;

FIG. 5B is a schematic drawing in section with portions broken awayshowing another example of a coupler assembly incorporating teachings ofthe present disclosure;

FIG. 5C is a schematic drawing in section taken along lines 5C-5C ofFIG. 5B, incorporating teachings of the present disclosure;

FIG. 5D is a schematic drawing in section taken along lines 5D-5D ofFIG. 5A incorporating teachings of the present disclosure;

FIG. 6A is a schematic drawing showing an exploded of one example of anintraosseous needle incorporating teachings of the present disclosure;

FIG. 6B is a schematic drawing showing an isometric view of anintraosseous biopsy needle incorporating teachings of the presentdisclosure;

FIG. 6C is a schematic drawing showing an isometric view of anotherintraosseous needle incorporating teachings of the present disclosure;

FIG. 7A is a schematic drawing showing an exploded view with portionsbroken away of the tips of an intraosseous needle set incorporatingteachings of the present disclosure;

FIG. 7B is a schematic drawing showing an exploded view with portionsbroken away of a beleved tip of an intraosseous needle set incorporatingteachings of the present disclosure;

FIG. 7C is a schematic drawing showing an exploded view with portionsbroken away of the tips of an intraosseous needle set or a cannulaincorporating teachings of the present disclosure;

FIG. 7D is a schematic drawing showing an exploded view with portionsbroken away of the tips of an intraosseous needle set or a cannulaincorporating teachings of the present disclosure;

FIG. 7E is a schematic drawing showing an exploded view of oneembodiment of the tip of an intraosseous device or cannula incorporatingteachings of the present disclosure;

FIG. 7F is a schematic drawing showing an exploded view of still anotherembodiment of a tip of an intraosseous needle or device incorporatingteachings of the present disclosure;

FIG. 8A is a schematic drawing partially in section and partially inelevation with portions broken away showing an exploded isometric viewof a mandrel operable to install a thread insert within portions of anintraosseous biopsy needle in accordance with teachings of the presentdisclosure;

FIG. 8B is a schematic drawing showing one example of a thread insertwhich may be disposed within the longitudinal bore of an intraosseousbiopsy needle in accordance with teachings of the present disclosure;

FIG. 8C is a schematic drawing in section with portions broken awayshowing one example of an intraosseous biopsy needle with a singlehelical thread disposed within one end of the biopsy needleincorporating teachings of the present disclosure;

FIG. 8D is a schematic drawing in section with portions broken awayshowing another example of an intraosseous biopsy needle with a singlehelical thread disposed within one end of the biopsy needle inaccordance with teachings of the present disclosure;

FIG. 8E is a schematic drawing in section and in elevation with portionsbroken away showing an intraosseous biopsy needle set including a trocarand a single helical thread disposed proximate one end of a generallyhollow cannula in accordance with teachings of the present disclosure;

FIG. 9 is a schematic drawing partially in section showing an isometricview of an intraosseous needle set penetrating bone incorporatingteachings of the present disclosure;

FIG. 10A is a schematic drawing partially in section showing an exampleof a vertebral procedure using the intraosseous (IO) medical devices andmedical procedures tray, wherein a powered driver is used to insert anIO device (needle/cannula) into a vertebral bone, incorporatingteachings of the present disclosure;

FIG. 10B is a schematic drawing showing partially in section an exampleof a vertebral procedure using the intraosseous (IO) medical devices andmedical procedures tray, wherein the powered device is detached from theintraosseous medical devices leaving the IO needle/cannula attached tothe vertebral bone, incorporating teachings of the present disclosure;

FIG. 10C is a schematic drawing partially in section showing an exampleof a vertebral procedure using the intraosseous medical devices andmedical procedures tray, a therapeutic agent may be delivered into theIO needle/cannula, incorporating teachings of the present disclosure;and

FIG. 10D is a schematic drawing partially in section showing an exampleof a vertebral procedure using the intraosseous medical devices andmedical procedures tray, wherein a trocar (e.g., for delivering atherapeutic agent, or for obtaining a biopsy) is inserted into thecannula attached to a vertebral bone, incorporating teachings of thepresent disclosure.

DETAILED DESCRIPTION OF THE DISCLOSURE

Apparatus, medical procedure trays, kits and methods incorporatingteaching of the present disclosure may by used for diagnostic evaluationand/or for the treatment of various bone related ailments. Preferredembodiments of the disclosure and various advantages may be understoodby reference to FIGS. 1A-10D, wherein like numbers refer to same andlike parts.

In some embodiments, teachings of the present disclosure may be used fortherapy and/or repair of fractures, such as but not limited to,vertebral fractures, or treatment of damaged bones in a patient's spine.Fractures of the spine are often due to osteoporosis, a progressive lossof bone tissue which depletes both collagen and calcium salts from bone.The bone tissue continues to weaken and is prone to fractures bycracking of the vertebral bones or by collapsing (compression) of thevertebral bones. People with osteoporosis rarely have any symptoms untilthe bone fractures occur. Vertebral compression fractures may also becaused by softening of bones due to aging or due to spreading of cancersto the vertebra or due to other cancers that can weaken bone.Compression of bony building blocks of the spine (vertebrae) causes acollapse of the vertebrae much like a sponge collapses under thepressure of one's hand. A fracture that collapses a spinal vertebra iscalled a vertebral compression fracture. Although in some instancesvertebral compression fractures may occur without pain, these fracturesoften result in a severe “band-like” pain that radiates from the spinearound both sides of the body. Over many years, spinal fractures reducethe height of the spine and the affected person becomes shorter.Conventional treatment of vertebral compression fractures includes painmedication, resting, avoiding injury, and using support braces.Therapies such as vertebroplasty, which involves stabilization of afractured vertebral body by injection of a surgical cement, have beenused to treat or ameliorate the symptoms associated with vertebralfractures.

Vertebroplasty is a non-surgical procedure, often performed by aradiologist, and involves inserting a surgical/bone cement into thecenter of the collapsed spinal vertebra in order to stabilize andstrengthen the crushed bone. The surgical/bone cement is a glue-likematerial (such as poly-methylmethacrylate (PMMA)) and maybe typicallyinserted with a needle and syringe through anesthetized skin into themidportion of the vertebra under the guidance of specialized x-rayequipment. Upon insertion the cement hardens and forms a cast-likestructure within the broken bone. The casting effect on the broken bonetypically provides pain relief and the newly hardened vertebra protectedfrom further collapse. Apart from pain relief, vertebroplasty allowsbetter mobility to patients.

In some embodiments, the present disclosure provides medical devices,medical procedure trays, kits and methods for performing vertebroplastyor other procedures associated with spinal treatments. A medicalprocedure tray for performing vetrebroplasty and/or other spinalprocedure may comprise an intraosseous (IO) device for penetratingvertebral bones such as an vertebral IO needle set, a coupler assembly,and a driver (manual or power driven) which may be non-sterile. Thecoupler assembly may comprise a containment bag or sterile glove thatmay be used to prevent direct contact of a non-sterile driver with asterile IO device, operator and patient during a medical procedure. Thecoupler assembly may be operable to releasably engage an intraosseousdevice with portions of a drive shaft extending from one end of apowered driver, to obtain a device similar to that depicted in FIG. 3Cor 4A. The coupler design allows for multiple use of a non-steriledriver for such procedures in conjunction with disposable sterile IOneedle sets and couplers. The powered driver may be used to insert anintraosseous device at an insertion site (power in) and also allow thepowered driver to “spin” the intraosseous device during removal from theinsertion site (power out). An intraosseous needle set may comprise acannula having a lumen and a trocar or a stylet operable to be slidablydisposed within the lumen of the cannula.

A vertebroplasty method using the devices, kits or trays of the presentdisclosure may compose: 1) penetrating a vertebral bone(fractured/compressed vertebral bone) using an intraosseous needlecomprising a cutting tip and a cannula having a lumen using a powereddriver and coupler assembly in a “power in” mode, the power driversuitably contained in a containment bag; 2) detaching the powered driverand coupler assembly from the IO needle inserted into the bone; 3)filling a trocar or stylet operable to be slidably disposed within thelumen of the cannula with surgical cement; 4) slidably disposing thetrocar or stylet with surgical cement into the cannula; 5) injecting thesurgical cement into the fractured bone; 6) detaching the trocar orstylet from the cannula; 7) reattaching the powered driver and couplerassembly to the cannula; and 8) withdrawing the cannula from thevertebral bone using the powered driver in a “power out” mode.

Typically a vertebroplasty procedure in accordance to the teachings ofthe disclosure, may utilize a bi-plane fluoroscopy imaging equipment toachieve accurate needle placement and delivery of accurate amounts ofbone cement. Penetration of bone and depth of insertion of a needle maybe guided by fluoroscopy or other imaging methods. In some embodiments,an operator may stop penetration when a decrease in resistance is felt,which may be indicative of passage through the hard cortex of bone intoinner bone tissues. In some embodiments, for medical procedures that mayrequire imaging or other visualization to guide an operator to insert anIO needle/device into a specific insertion site, hubs of the needle maybe designed to be small and unobtrusive to the visualization method. Forother embodiments one or more biopsy samples may be taken afterinserting an intraosseous needle into a vertebral bone and prior toinjecting cement and/or therapeutic agents into the vertebral bone.

Various spinal procedures or other medical procedures may be combinedwith suitable cleaning, disinfecting the insertion site prior toinsertion of a needle. A patient may be locally or completelyanesthetized based on the need. The site of insertion may beappropriately dressed and cared for after the procedure.

The term “containment bag” as used in this application may include anysterile sleeve, sterile envelope, sterile glove, sterile enclosure,sterile bag or any other device incorporating teachings of the presentdisclosure and operable to allow engaging a non-sterile device with asterile device and conducting a medical procedure requiring a sterilefield or sterile environment.

For some applications a non-sterile powered driver (or manual driver)may be placed in a containment bag incorporating teachings of thepresent disclosure and engaged with a sterile intraosseous device foruse during various medical procedures requiring a sterile field orsterile environment. Such containment bags may be attached to a couplerassembly or any other device incorporating teachings of the presentdisclosure to prevent the non-sterile powered driver from contaminatingthe sterile intraosseous (IO) device during and after engagement of thenon-sterile powered driver with the IO device.

The term “driver” as used in this application may include any type ofpowered driver (or manual driver) satisfactory for inserting anintraosseous (IO) device into a selected portion of a patient's bone.Such powered drivers often rotate a drive shaft extending therefrom.However, various teachings of the present disclosure may be used withpowered drivers that reciprocate an associated drive shaft (notexpressly shown).

Various techniques may be satisfactorily used to releasably engage orattach an IO device with a powered driver in accordance with teachingsof the present disclosure. For example a wide variety of couplerassemblies, port assemblies, connectors, receptacles, fittings, hubs,hub assemblies, latching mechanisms and/or other types of connectingdevices incorporating teachings of the present disclosure may besatisfactorily used to releasably engage an IO device with a powereddriver.

Various types of coupler assemblies incorporating teachings of thepresent disclosure may be satisfactorily used to releasably engage oneend of a shaft extending from a driver with one end of an intraosseousdevice. For some embodiments the powered driver may include a driveshaft having one end with a generally hexagonal cross section operableto be releasably engaged with a latch mechanism disposed in one end of acoupler assembly. For some embodiments a coupler assembly incorporatingteachings of the present disclosure may be referred to as a “hands free”coupler, a quick disconnect or quick release coupler and/or portassembly.

Respective latch mechanisms may be disposed proximate a first end and asecond end of a coupler assembly in accordance with teachings of thepresent disclosure. Pushing one end of a drive shaft extending from apowered driver into the second end of the coupler assembly may result inan annular recess disposed in the one end of the drive shaft “snapping”into releasable engagement with the respective latch mechanism. Pushingone end of an intraosseous device into the first end of the couplerassembly may result in an annular recess in the one end of theintraosseous device “snapping” into releasable engagement with therespective latch mechanism.

For some embodiments, a coupler assembly or port assembly may be engagedwith a containment bag or sterile sleeve in accordance with teachings ofthe present disclosure. Coupler assemblies and/or hub assembliesincorporating teachings of the present disclosure allow easy separationof an associated powered driver from an IO device such that the IOdevice may remain in place in a patient to allow bone marrow aspirationor removal of bone and/or bone marrow biopsy specimens. Such couplerassemblies and/or port assemblies may also allow an associated powereddriver to “spin” or rotate an attached IO device while withdrawing an IOdevice from an insertion site or changing the depth of penetration of anIO device in a target area. Rotating the IO device during withdrawal orchanging depth (power out) may substantially improve patient comfort andreduce potential trauma to bone and soft body tissue proximate aninsertion site.

A powered driver may be used to insert an IO device incorporatingteachings of the present disclosure into a selected target area ortarget site in ten seconds or less. However, various teachings of thepresent disclosure are not limited to use with powered drivers. Manualdrivers and spring powered drivers may also be used with IO devicesincorporating teachings of the present disclosure.

Examples of manual drivers are shown in copending patent applicationSer. No. 11/042,912 entitled Manual Intraosseous Device filed Jan. 25,2005 (now U.S. Pat. No. 8,641,715).

The term “fluid” may be used in this application to include liquids suchas, but not limited to, blood, water, saline solutions, IV solutions,plasma or any mixture of liquids, particulate matter, dissolvedmedication and/or drugs associated with biopsy or aspiration of bonemarrow or communication of fluids with bone marrow or other targetsites. The term “fluid” may also be used in this patent application toinclude any body fluids and/or liquids containing particulate mattersuch as bone marrow and/or cells which may be withdrawn from a targetarea.

The terms “harvest” and “harvesting” may be used in this application toinclude bone and/or bone marrow biopsy and bone marrow aspiration. Boneand/or bone marrow biopsy (sometimes referred to as “needle biopsy”) maybe generally described as removing a relatively small piece or specimenof bone and/or bone marrow from a selected target area for biopsypurposes. Bone marrow aspiration (sometimes referred to as “bone marrowsampling”) may be generally described as removing larger quantities ofbone marrow from a selected target area. Relatively large quantities ofbone marrow may be used for diagnostic, transplantation and/or researchpurposes. For example some stem cell research techniques may requirerelatively large quantities of bone marrow.

The terms “insertion site,” “penetration site,” and “installation site”may be used in this application to describe a location on a bone atwhich an intraosseous device may be inserted or drilled into the boneand associated bone marrow. Insertion sites, penetration sites andinstallation sites are generally covered by skin and soft tissue. Forexample, for a vertebral procedure an insertion site may be a vertebraldisc bone.

The term “intraosseous (IO) device” may be used in this application toinclude, but is not limited to, any hollow needle, hollow drill bit,penetrator assembly, bone penetrator, catheter, cannula, trocar, stylet,inner penetrator, outer penetrator, IO needle, biopsy needle, aspirationneedle, IO needle set, biopsy needle set or aspiration needle setoperable to penetrate and/or provide access to an intraosseous space orinterior portions of a bone. Such IO devices may be formed, at least inpart, from metal alloys such as 304 stainless steel and otherbiocompatible materials associated with needles and similar medicaldevices.

Various types of IO devices may be formed in accordance with teachingsof the present disclosure. Examples of such IO devices may include, butare not limited to, IO needle sets for delivering therapeutic agents, IOneedle sets for delivering a bone cement, vertebral IO needles, biopsyneedles, biopsy needle sets, aspiration needles and aspiration needlesets. However, a wide variety of other IO devices may be formed inaccordance with one or more teachings of the present disclosure. Such IOdevices may or may not include a trocar and/or a stylet.

For some applications, a trocar and/or a stylet may be inserted into agenerally hollow, longitudinal bore or lumen in an associated catheteror cannula. The first end of the second hub may be releasably engagedwith second end of the first hub to releasably dispose the stylet ortrocar within the longitudinal bore of the cannula or catheter. Thepresent disclosure is not limited to IO needle sets such as therapeuticagent delivery IO needle sets, vertebral IO needles, aspiration needlesets, or biopsy needle sets as discussed in this application.

The term “target area” may be used in this application to describeselected portions of a bone cavity or locations in a bone cavity intowhich a therapeutic agent may be delivered or from which associated bonetissue and/or bone marrow may be harvested in accordance with teachingsof the present disclosure.

Many currently available techniques for providing a therapeutic agentand obtaining a bone sample and/or harvesting bone and/or bone marrowmay require more than one penetration into a bone and associated bonemarrow to retrieve an adequate sample of bone and/or bone marrow.Separate diagnostic and therapeutic procedures are normally requiredeven for diagnosis and therapy to the same bone, thereby requiringmultiple insertions into the same bone at different times. Further,multiple penetration sites may be required in the same bone if a biopsyspecimen is not satisfactorily retrieved at the first penetration site.Medical personnel may need to insert an IO needle into several differentpenetration sites on the same bone to obtain adequate quantities of bonemarrow for transplant or stem cell research. For example obtainingsufficient quantities of bone marrow from a patient's pelvis may requiresix or more insertion sites. Multiple insertions may be extremelypainful for a patient and may deter some people from donating bonemarrow. Multiple insertions may also cause fatigue in medical personnelperforming such procedures with manual IO devices. Multiple schedulingfor therapeutic procedures separate from diagnostic procedures also addsto trauma and cost for a patient.

For some applications, an IO needle or other IO device may be formedwith a first end operable to penetrate bone and/or associated bonemarrow. A connector or hub may be attached to a second end of the IOneedle or other IO device. Such connectors or hubs may be operable toreleasably engage the IO needle or IO device with a powered driver, amanual driver and/or a coupler assembly.

IO needle sets and other IO devices incorporating teachings of thepresent disclosure may include a first IO device such as a cannula,catheter or outer penetrator and a second IO device such as a stylet,trocar, syringe, or inner penetrator. Various types of cutting surfacesmay be formed proximate a first end of the first IO device and a firstend of the second IO device. The cutting surface of the first IO deviceand the cutting surface of the second IO device may cooperate with eachother to penetrate bone and/or associated bone marrow.

A first connector or first hub may be used to releasably engage thefirst IO needle or IO device with the second IO needle or IO device. Forexample an IO needle set may include a first connector or a first hubwith a generally hollow cannula, catheter or outer penetrator attachedthereto and extending from a first end of the first hub. A second end ofthe first hub may be operable to be releasably engaged with a first endof a second connector or a second hub. A stylet, trocar or innerpenetrator may also be attached to and extend from the first end of thesecond hub. The second end of the first hub may include an opening sizedto allow inserting the stylet, trocar or inner penetrator through theopening and a lumen in the cannula, catheter or outer penetrator.

A second end of the second hub may be operable to be releasably engagedwith a first end of a coupler assembly incorporating teachings of thepresent disclosure. One end of a shaft extending from a powered driveror a manual driver may be releasably engaged with a second end of thecoupler assembly.

In some embodiments of the present disclosure, the dimensions of thehubs may be designed to be unobtrusive or minimally obtrusive to animaging method that may be used to image the site of insertion and amedical procedure being performed such as the delivery of a medicamentto a specific site.

Additional details concerning powered drivers, connectors, hubs, and IOdevices may be found in co-pending patent application entitled “PoweredDriver Intraosseous Device and Methods To Access Bone Marrow,” Ser. No.12/061,944, filed Apr. 3, 2008, which claims priority from a provisionalpatent application with the same title filed on Apr. 4, 2007.

Various features of the present disclosure may be described with respectto powered driver 200, coupler assemblies 250 and 250 a, hub assemblies130 (130 a, 130 b, 130 c and 130 d), hubs, 96, 140, 150, IO needle sets100, 100A, 100 b, 100 c and 100 d, including IO needles, vertebralneedles, IO biopsy needles, IO aspiration needles, and containment bag170. However, the present disclosure is not limited to such powereddrivers, coupler assemblies, hub assemblies, IO needle sets, and/orcontainment bags. A wide variety of intraosseous devices, hubassemblies, coupler assemblies and/or containment bags may be formed inaccordance with teachings of the present disclosure with variousdimensions and/or configurations.

FIGS. 1A and 1B show some examples of medical procedure trays and/orkits which may contain one or more intraosseous devices and/or othercomponents incorporating teachings of the present disclosure. Forexample, medical procedure tray 20 as shown in FIG. 1A may include afirst tray 20 a comprising an intraosseous needle set with needles 100 aand 100 b (e.g., an IO needle set for penetration and delivery of amedicament to a vertebral bone), funnel 80 and sharps container 64; asecond tray 20 b comprising an intraosseous biopsy needle set withneedles 100 c and 100 d, funnel 80 and sharps container 64 incorporatingvarious teachings of the present disclosure; and a third tray 20 ccomprising a coupler assembly 250, containment bag 170, feet 5 andsecond end of the coupler assembly 252 that may be releasably attachedto power driver 200 (not expressly shown). Feet 5 provide support fortray 20 c. Trays 20 a, 20 b and 20 c may be enclosed in tray 20 andcovered with a detachable paper or plastic wrap 2. In some embodiments,an additional tray comprising an IO aspiration system for obtaining bonemarrow may also be comprised in tray 20 (not expressly depicted).

For delivery of a therapeutic agent to bone and/or for removal of abiological specimen from a bone the needles 100 b or 100 d as depictedin FIGS. 1A and 1B may also be referred to as an “ejector rod.” Anejector rod, such as 100 b or 100 d, may be slidably disposed into ahollow cannula 100 of an IO needle to deliver a medicament or obtain abiological sample from a bone. In the case of a biopsy ejector rod, ahelical thread, operable to be wound back by a mandrel, may be disposedin the cannula. Upon contact with bone tissue the helical thread may bewould back to retrieve the biopsy sample.

The length of ejectors 100 b or 100 d may be selected to be greater thanthe length of a lumen in an associated IO needle. Handle or hub 96 maybe disposed on second end 92 of ejectors 100 b or 100 d. See FIG. 1D.The dimensions and configuration of first end 91 of ejector rod 100 b or100 d may be selected to be compatible with inserting first end 91through an opening in the first end 111 of an associated IO and/orbiopsy needle 100. Various types of ejectors, ejector rods, funnelsand/or ejector funnels may also be used with an IO needle, a vertebralneedle, an IO biopsy needle, IO aspirator needle and/or otherintraosseous devices incorporating teachings of the present disclosure.

Medical procedure tray 20 as shown in FIG. 1B may include first tray 20a comprising an intraosseous needle set 100 a and 100 b (for example,vertebral IO needles), funnels 80 and sharps container 64; and secondtray 20 c comprising a coupler assembly 250, containment bag 170, feet 5and second end of the coupler assembly 252 that may be releasablyattached to power driver 200 (not expressly shown). IO needle sets 100may comprise one or more cannulas, stylets, trocars, and/or cuttingneedle tips. Feet 5 provide support for tray 20 c. Trays 20 a, 20 b and20 c may be enclosed in tray 20 and covered with a detachable paper orplastic wrap 2.

Medical procedure trays and/or kits formed in accordance with teachingsof the present disclosure may provide a support or base for variouscomponents such as one or more of the following: IO devices and needles100, coupler assembly 250, funnel 80 and/or sharps protector 64 to allowan operator or user to perform various functions without requiring thatthe operator or user hold or manipulate the respective component. Forexample medical procedure tray 20 c as shown in FIGS. 1A and 1B mayposition and support coupler assembly 250 such that one end of a powereddriver 200 may be inserted (pushed) into releasable engagement withsecond end 252 of coupler assembly 250. The powered driver 200 may thenbe used to withdraw coupler assembly 250 from medical procedure tray 20c without requiring an operator or user to directly hold or manipulatecoupler assembly 250.

FIG. 1E depicts a detailed structure of funnels 80 of FIGS. 1A, 1B, 1Cand 1D. Funnel 80 a, as in FIG. 1E, may be positioned and supportedwithin medical procedure trays 20 a or 20 b such that one end of anintraosseous device may be inserted (pushed) into funnel 80 a. Funnel 80a may be withdrawn from medical procedure tray 20 a and/or 20 b withoutrequiring that an operator or user directly hold or manipulate funnel 80a.

Funnel 80 a may be slidably disposed in holder 56 in medical proceduretray 20 a in a generally vertical position. See FIGS. 1A, 1B, 1C and 1D.As a result, first end 81 a of funnel 80 a may be oriented in a positionto allow inserting one end of IO biopsy needles such as the cannuladepicted herein as 100 a or 100 c therein. Longitudinal passageway 84proximate first end 81 a may include a sticking tapered portion operableto maintain contact with one end of an IO set such as the outer cannula100 a or 100 c. An IO needle set or cannula may then be manipulated topull funnel 80 a from holder 56. Funnel 80 a may serve as a sharpsprotector for the one end of an intraosseous device inserted therein.

For some applications, funnels formed in accordance with teachings ofthe present disclosure may include a respective first opening formed ata first end and a respective second opening at a second end of thefunnel. The first opening and the second opening may have differentinside diameters. For example, the first opening may be sized toaccommodate inserting an IO needle, a vertebral needle and/or a biopsyneedle therein while the second opening may have a reduced insidediameter which prevents inserting the needle therein. The second openingmay be sized to only accommodate one end of an associated ejector rod.For some applications, a longitudinal passageway may extend between thefirst end and the second end of the funnel. Tapered surfaces may beformed within the longitudinal passageway adjacent to the first end. Thetapered surfaces may function as a “one way” connector such that when anIO needle, a vertebral needle, and/or an IO biopsy needle is insertedtherein, the funnel will be securely engaged with the first end of theneedle. The funnel may then function as a sharps protector for the firstend of the needle.

Each sharps protector 64 may also be positioned and supported withinmedical procedure trays 20 a and/or 20 b to allow inserting (pushing)one end of an intraosseous device or any other medical device requiringsharps protection into sharps protector 64 without requiring that anoperator or user to directly hold or manipulate the associated sharpsprotector 64. Medical procedure trays 20, 20 a, 20 b, 20 c, couplerassemblies 250 and other components formed in accordance with teachingsof the present disclosure may substantially reduce the number ofopportunities for an accidental “needle stick” and/or dropping,contaminating or other problems associated with handling andmanipulating various components disposed within an associated medicalprocedure tray.

Medical procedure trays and kits formed in accordance with teachings ofthe present disclosure may have a wide variety of configurations and/ordimensions. For some applications, a kit holding intraosseous devices inaccordance with teachings of the present disclosure may have an overalllength of approximately four and one-half inches, a width ofapproximately three inches and a depth of approximately two inches.Various heat sealing techniques may be satisfactorily used to place aremovable cover (not expressly shown) over a medical procedure tray orkit incorporating teachings of the present disclosure.

Sharps protectors 64 may include hard foam or claylike material 66disposed therein. Intraosseous devices such as vertebral needle sets,other IO needle sets, aspiration needle sets and biopsy needle setstypically have respective sharp tips and/or cutting surface operable topenetrate skin, soft tissue and bone. The sharp tips and/or cuttingsurface of such intraosseous devices may be inserted into hard foam orclaylike material 66 after completion of a medical procedure using therespective intraosseous device.

For some applications, medical procedure tray 20 or 20 a may be referredto variously as a ‘vertebral procedure tray,” and/or “vertebroplastytray,” and/or a “tray for providing access to deliver therapeutic agentsto bone,” and/or a “therapeutic and diagnostic procedures tray.” Forsome applications, medical procedure tray 20 b may sometimes be referredto as “bone and/or bone marrow biopsy procedure trays” or “biopsyprocedure trays” or “bone marrow biopsy kits.” For some applications,medical procedure tray 20 a may be referred to as a “bone marrowaspiration tray,” “aspiration procedure tray” or “bone marrow aspirationkit”. For some applications, medical procedures tray 20 c may bereferred to as “coupler assembly tray” or “sterile glove tray.”

Medical procedure trays 20 a, 20 b and/or 20 c may be formed fromvarious polymeric materials compatible with sterile packaging andstorage of various components disposed within each medical proceduretray. For some applications ethylene oxide sterilization techniques maybe used during assembly and packaging of medical procedure trays 20 a,20 b and 20 c. However, other sterilization procedures may be used asappropriate.

In some embodiments, medical procedures trays of the disclosure may bestored at temperatures ranging from between about −20° C. to about 50°C.

Respective covers (not expressly shown) may be placed over each medicalprocedure tray 20 a, 20 b and 20 c as part of an associatedsterilization and packaging process. Such covers may be removed prior touse of various components disposed within each medical procedure tray. Arespective cover 2 may be placed on the main tray 20 that comprises twoor more of trays 20 a, 20 b and/or 20 c.

Medical procedure tray, vertebroplasty tray, vertebral procedure tray,diagnostic and therapeutic tray, or tray for providing a medicament to abone, 20 a (see FIG. 1C) may include elongated slot 22 with appropriatedimensions for an associated intraosseous device such as, but notlimited to, IO needle set 100, or 100 a and 100 b. The dimensions andconfiguration of slot 22 may be selected to accommodate the combinedlength of hub assembly 130 and cannula 110 a extending therefrom. Oneend of slot 22 may be sized to accommodate the dimensions andconfiguration of hub assembly 130. Enlarged openings or finger slots 24may also be provided to accommodate inserting and removing IO needle set100 from slot 22. Various details associated with IO needle set 100 willbe discussed later with respect to FIG. 6A-8E.

In FIGS. 1C and 1D, sharps protector 64 may be disposed within holder 26of medical procedure tray 20 a or 20 b. A pair of finger slots 28 mayalso be formed in tray 20 a or 20 b to accommodate inserting andremoving sharps protector 64 from holder 26 a. Holder 26 b may also beformed in tray 20 a along with associated finger slots 28. An additionalsharps protector or other components may be disposed within holder 26 b.The dimensions/configurations of slot 22 and holders 26 a and 26 b maybe varied as desired for respective components which will be disposedtherein.

Medical procedure trays 20 b (See FIG. 10) may include elongated slots30 and 32. The dimensions and configuration of elongated slot 30 may beselected to accommodate placing ejector 110 d therein. The dimensionsand configuration of elongated slot 32 may be selected to accommodateplacing an intraosseous device such as a biopsy system with biopsyneedle set 100 c and 100 d therein (as depicted) or an aspiration systemwith an aspiration needle (not depicted).

One end of elongated slot 30 may have configuration and dimensionsselected to accommodate the configuration and dimensions of handle 96disposed on second end 92 of injector rod 100 d (See FIG. 1D). A pair offinger slots 34 may be formed as part of elongated slot 30 to allowinstalling and removing ejector 100 d. One end of elongated slot 32 maybe operable to accommodate the configuration and dimensions associatedwith hub assembly 130 a of IO biopsy needle set 100 c. A pair of fingerslots 36 may also be provided as part of elongated slot 32 toaccommodate inserting and removing IO biopsy needle set 100 c fromelongated slot 32.

Tray 20 b may also include holder 38 disposed adjacent to elongated slot30. Holder 38 may have a configuration and dimensions compatible withreleasably placing funnel 80 therein. One or more specimen or samplecontainers or cups (not expressly shown) may be provided in biopsy tray20 b. Biopsy specimen or sample containers may include a cavity sized toreceive a biopsy specimen from biopsy needle set 100 c and 100 d. Funnelholders 38 may be formed in biopsy procedure tray 20 b adjacent toejector 100 d to ensure that funnel 80 is readily available to assistwith removing a biopsy specimen from biopsy needle set 100 d.

Medical procedure trays 20 as shown in FIGS. 2A and 2B represent otherexample of a medical procedure tray formed in accordance with teachingsof the present disclosure. FIGS. 2A and 2B depict trays that comprisemedical procedure tray 20 c and either trays 20 a and 20 b; or 20 c and20 a or 20 b. Containment bag 170 and power driver 200 are also shown.FIG. 2B shows power driver 200 being enclosed in containment bag 170.Containment bag 170 may comprise a flexible stay 180, a flap 174, andmay further comprise an adhesive strip 4 all of which may be used tocontain a non-sterile power driver 200 and prevent contamination of IOdevices, IO needles or coupler by the non-sterile power driver.Containment bag 170 may also prevent contamination of the power driver200 by pathogens in bodily fluids that may leak out during a medicalprocedure. The configuration and dimensions of flexible stay 180 may beselected to accommodate inserting and removing a powered driver or othernon-sterile medical device therefrom.

A combined medical procedure tray(s) (such as 20 in FIG. 1A or 20 inFIG. 1B) may be sterilized after being assembled. One benefit of suchsterilization may include, but is not limited to, providing a sterilizedcontainment bag which may be used to engage a non-sterile medical devicewith a sterile medical device in accordance with teachings of thepresent disclosure.

One of the benefits of the present disclosure may include being able toreleasably engage one end 211 of a powered driver 200 with one end 252of a coupler assembly 250, releasably engage one end 102 of an IO needle100 (such as a vertebral needle or a biopsy needle) with an opposite end251 of the coupler assembly 250, insert “power in” another end 101 ofthe IO needle 100 into a selected target area, deliver one or moremedicaments into the target area using one or more components of an IOdevice or needle set 100, “power out” the IO needle 100 with a highdegree of confidence that a specimen (such as a biopsy sample) will bedisposed therein and insert the other end 101 of the IO needle into afunnel to provide both sharps protection and removal/storage of thespecimen. Any direct contact between an operator and the IO needle maybe limited to pushing one end of the IO needle into a respective end ofthe coupler assembly.

Another benefit of the present disclosure is to insert “power in” afirst IO needle (such as a cannula) into a bone to provide access to thebone followed by slidably inserting a second IO needle (such as atrocar) into the first IO needle. The second needle may be operable todeliver a therapeutic agent to bone or may be operable to obtain aspecimen from bone. The second needle may be slidably removed from thefirst IO needle. In one example, a second needle may be a biopsy needlethat may be inserted into the cannula of a first needle to obtain abiopsy and slidably removed after the sample is obtained. Anotherneedle, a third IO needle (a trocar) operable to deliver a therapeuticagent may then be slidably inserted into the first needle (cannula) anda therapeutic agent may be delivered. Multiple needles may be insertedfor different diagnostic/therapeutic purposes repeatedly through thefirst cannula needle without the need for multiple insertions into bone.Upon completion of the medical procedures the first needle may then be“powered out”. In some embodiments, the medical procedure devices andtrays and methods of the present disclosure may be used to performmultiple procedures with one insertion into the bone.

A pair of holders or clamps 26, 26 a, 26 b (FIGS. 2A and 2B) may also beformed in medical procedure tray 20 c adjacent to holder for couplerassembly 250. Such clamps 26 a and 26 b may be designed to respectivelyaccommodate first end 181 and second end 182 of flexible stay 180disposed on opening 172 of containment bag 170. Coupler assembly 250 mayalso be installed in holder 58 of coupler assembly tray 20 c with firstend 251 down and second end 252 looking up. FIGS. 2A and 2B shows apower driver 200 being placed on second end 252 of a coupler assembly250 in exemplary tray 20, where exemplary tray 20 comprises tray 20 c asdescribed above and may comprise trays 20 a and 20 b or tray 20 a or mayeven comprise a tray 20 d (not depicted). FIG. 2B depicts a raised bag170 covering powered driver 200, showing features of the containment bag170 including flap 174, opening 172, flexible stay 180, respective ends181 and 182 of the flexible stay, and adhesive strip 4 in an exemplarymedical procedures tray as described earlier in this paragraph. However,the present disclosure is not limited to using flaps and adhesivematerials to close an opening in a containment bag and other means maybe used to close and seal a containment bag.

FIGS. 3A-3C illustrate one procedure for placing a powered driver 200within containment bag 170 incorporating teachings of the presentdisclosure. Containment bag 170 may be formed from generally flexible,fluid impervious material such as a plastic, which may also besterilized using conventional sterilization techniques. Containment bag170 may be used to prevent a non-sterile powered driver 200 fromcontaminating a sterile intraosseous device 100 and/or a patient,particularly during an IO therapeutic and/or IO diagnostic procedure.Containment bag 170 may be operable to form a fluid barrier withadjacent portions of housing assembly 270 of coupler assembly 250. Atthe same time, coupler assembly 250 may allow powered driver to rotatean intraosseous device 100 releasably engaged with first end 251 ofcoupler assembly 250 without damage to containment bag 170.

A non-sterile person (not expressly shown) may next insert power driver200 into coupler assembly 250 and extend containment bag 170 (FIGS.3A-3C). First end 181 and second end 182 of flexible stay 180 may beremoved from respective clamps or holders in medical procedure tray 20 cto allow manually lifting second opening 172 upwardly relative topowered driver 200. See FIGS. 2A-2B and 3A-3C. Containment bag 170 maycontinue to be raised to a fully extended position with powered driver200 disposed therein. See FIG. 3B. Flap 174 may then be placed oversecond opening 172 and further sealed using the adhesive strip 4proximate 172. Containment bag 170 with powered driver 200 disposedtherein and coupler assembly 250 may then be removed from holder 58 ofmedical procedure tray 20 c (FIGS. 2A-2B). Various commerciallyavailable low strength adhesive materials may be satisfactorily used toprovide releasable engagement between flap 174 proximate opening 172 ofcontainment bag 170.

Housing assembly 270 and/or housing segments 280 and 290 of couplerassembly 250 may remain relatively stationary during rotation ofelongated core 260. In some embodiments, spinner 10 may be rotated forinsertion and securing of IO device at end 251. See FIGS. 3A-3C and4A-4B. For example portions of housing assembly 270 such as flange 254extending from second end 252 of coupler assembly 250 may be attached tocontainment bag 170 and remain relatively stationary while powereddriver 200 rotates elongated core 260 and IO needle set 100 extendingtherefrom.

For some applications, powered driver 200 may be directly placed into acontainment bag 170 and engaged with coupler assembly 250. For otherapplications, a non-sterile powered driver may be inserted intocontainment bag 170 in connection with removing coupler assembly 250from a medical procedure tray.

For some applications, a protective cover (not expressly shown) may beremoved from medical procedure tray 20 c. End 224 extending from driveshaft 222 of powered driver 200 may then be inserted through opening 172of containment bag 170 and releasably engaged with second end 252 ofcoupler assembly 250 (see FIG. 4C and FIGS. 3A-3C).

Typical procedures associated with using a medical procedure tray or kitincorporating teachings of the present disclosure may include thefollowing steps. Medical procedure tray 20 may be placed at a desiredlocation for performing an associated medical procedure. For examplemedical procedure tray 20 may be placed on a table or cart adjacent to asurgical table on which a bone therapeutic procedure, a vertebralprocedure, a bone or bone marrow biopsy procedure, and/or a bone marrowaspiration procedure may be performed.

An associated cover 2 may be removed from medical procedure tray 20 by asterile person. A non-sterile person may then pick up and insertnon-sterile powered driver 200 into flexible stay 180 such as shown inFIG. 3A. End 224 of drive shaft 222 of powered driver 200 may “snap”into place within second end 252 of coupler assembly 250. A sterileperson may then lift containment bag 170 up and over powered driver 200(as shown in FIG. 3B), and fold flap 174 over to secure with adhesivestrip 4 which will result in containing the power driver 200 (notexpressly shown).

The sterile person may then grasp handle 214 of powered driver 200through containment bag 170 and lift powered driver 200 with couplerassembly 250 attached thereto from holder 58 disposed in tray 20 c. Thesterile person may then remove an intraosseous (IO) device/needle 100from medical procedure trays 20 a or 20 b and insert second end 102 ofIO device/needle 100 into first end 251 of coupler assembly 250. A“snap” may be felt when second end 102 of IO device/needle 100 (or anyother intraosseous device incorporating teachings of the presentdisclosure) is releasably latched within first end 251 of couplerassembly 250. A needle safety cap (not expressly shown) may be removedfrom first end 101 of IO needle 100 after releasably engaging second end102 with first end 251 of coupler assembly 250.

Powered driver 200 disposed within containment bag 170 along withcoupler assembly 250 and IO needle 100 extending there from may be heldin one hand while a sterile person identifies the insertion site withthe other hand. Powered driver 200 may be positioned over the insertionsite to introduce first end 101 of IO needle set 100 through the skin inthe direction and towards the bone. Upon contact with the bone theoperator may squeeze button or trigger 246 and apply relatively steadygentle pressure to handle 214 of powered driver 200. Upon penetration ofthe bone cortex, the operator may release trigger 246 to stop furtherinsertion of first end 101 of IO needle 100.

First housing segment 280 may then be activated to release second end102 of IO needle 110 a from engagement with coupler assembly 250. Secondhub 150 a may then be rotated counterclockwise to disengage second hub150 a and associated stylet 120 from first hub 140 a. See FIGS. 5A-5Band 6A-6C. Stylet 120 may then be pulled out and removed from IO needleor cannula 111 a. First end 121 of stylet 120 (FIG. 6C) may then beinserted into sharps protector 64 of medical procedure tray 20. Uponcompletion of an appropriate IO procedure second hub 150 a may bereengaged with first hub 140 a (see FIGS. 6A and 6B). First end 251 ofcoupler assembly 250 may then be reengaged with second end 102 of IOneedle set 100 a to rotate or spin IO needle set 100 a while withdrawingfrom the insertion site. After removal from the insertion site, secondend 102 of IO needle set 100 a may be disengaged from coupler assembly250. First end 101 of IO needle set 100 a may then be inserted intosharps container 64.

In general, after completion of a bone related medical procedure, suchas vertebroplasty, other spinal procedures, delivery of a medicament toa bone, a bone marrow aspiration procedure, a bone and/or bone marrowbiopsy procedure and/or other medical procedures using an IO device 100,the sharp end or sharp tip of all components of the intraosseous devicemay be inserted into material 66 in sharp protector 64 for furtherdisposal in accordance with the appropriate procedures.

Powered driver 200 as shown in FIGS. 3A-3C, and 4A-4C may besatisfactorily used to insert an intraosseous device incorporatingteachings of the present disclosure into a bone and associated bonemarrow. However the disclosure is not limited to this particular powerdriver and any power driver may be used to practice the presentembodiments.

Powered driver 200 may include housing 210 having a generalconfiguration similar to a small pistol defined in part by handle 214.Various components associated with powered driver 200 may be disposedwithin housing 210 including handle 214. For example a power source suchas battery pack 216 may be disposed within handle 214. Battery pack 216may have various configurations and dimensions. Battery pack maycomprise a lithium chloride battery.

Housing 210 including handle 214 may be formed from relatively strong,heavy duty polymeric materials such as polycarbonates or othersatisfactory materials. For some applications housing 210 may be formedin two halves (not expressly shown) which may be joined together with afluid tight seal to protect various components of powered driver 200disposed therein.

Motor 218 and gear assembly 220 may be disposed within portions ofhousing 210 adjacent to handle 214. Motor 218 and gear assembly 220 maybe generally aligned with each other. Motor 218 may be rotatably engagedwith one end of gear assembly 220. Drive shaft 222 may be rotatablyengaged with and extend from another end of gear assembly 220 oppositefrom motor 218. For some applications both motor 218 and gear assembly220 may have generally cylindrical configurations.

Motors and gear assemblies satisfactory for use with powered driver 200may be obtained from various vendors. Such motor and gear assemblies maybe ordered as “sets” with one end of each motor securely attached to anadjacent end of an associated gear assembly. A drive shaft havingvarious dimensions and/or configurations may extend from the gearassembly opposite from the motor. Such gear assemblies may sometimes bereferred to as “reduction gears” or “planetary gears”. The dimensionsand/or configuration of housing 210 may be modified to accommodate anassociated motor and gear assembly.

Distal end or first end 211 of housing 210 may include an opening (notexpressly shown) with portions of drive shaft 222 extending therefrom.For some applications end 224 or the portion of drive shaft 222extending from first end 211 of housing 210 may have a generallyhexagonal cross section with surfaces 226 disposed thereon. Receptacle263 disposed in second end 252 of coupler assembly 250 may have amatching generally hexagonal cross section. See FIGS. 5A-5B.

Surfaces 226 may extend generally parallel with each other and parallelwith respect to a longitudinal axis or rotational axis (not expresslyshown) associated with drive shaft 222. One or more tapered surfaces 228may also be formed on end 224 to assist with releasably engaging powereddriver 200 with coupler assembly 250. See FIGS. 5A-5B. The end of adrive shaft extending from a powered driver may have a wide variety ofconfigurations.

A drive shaft having desired dimensions and configuration may extendfrom the gear assembly opposite from the motor. The drive shaft may beprovided as part of each motor and gear assembly set. The dimensionsand/or configuration of an associated housing may be modified inaccordance with teachings of the present disclosure to accommodatevarious types of motors, gear assemblies and/or drive shafts. Forexample, powered drivers used with vertebral IO needles, aspirationneedles and/or biopsy needles may include gear assemblies with largerdimensions required to accommodate larger speed reduction ratios, forexample between 60:1 and 80:1, resulting in slower drive shaft RPM's.Powered drivers used to provide intraosseous access during emergencymedical procedures may operate at a higher speed and may include gearassemblies having a smaller speed reduction ratio, for example between10:1 and 30:1, resulting in higher drive shaft RPM's. For someapplications, the difference in size for gear assemblies may result inincreasing the inside diameter of an associated housing by approximatelytwo to three millimeters to accommodate larger gear assembliesassociated with powered drivers used to insert vertebral JO needles,biopsy needles and/or aspiration needles.

Coupler assemblies having corresponding openings or receptacles may bereleasably engaged with end 224 extending from first end 211 of powereddriver 200 or end 224 a extending from first end 211 of powered driver200 a. For example, end 224 extending from first end 211 of housing 210may be releasably engaged with receptacle 264 disposed proximate secondend 252 of coupler assembly 250 as shown in FIGS. 1A-1B, 2A-2B, 3A-3Cand 5A-5D.

For some applications thrust bearing 241 may be disposed between firstend or distal end 211 of housing 210 and adjacent portions of gearassembly 220. See FIG. 4C. Thrust bearing 242 may be disposed betweensecond end or proximal end 212 of housing 210 and adjacent portions ofmotor 218. Thrust bearings 241 and 242 may limit longitudinal movementof motor 218, gear assembly 220 and drive shaft 222 within associatedportions of housing 210.

Trigger assembly 244 may also be disposed within housing 210 proximatehandle 214. Trigger assembly 244 may include trigger or contact switch246. See FIG. 4C. Motor 218 may be energized and deenergized byalternately depressing and releasing trigger 246. Electrical circuitboard 247 may also be disposed within housing 210. Electrical circuitboard 247 may be electrically coupled with trigger assembly 244, motor218, power supply 216 and indicator light 248.

For some applications indicator light 248 may be a light emitting diode(LED) or a small more conventional light bulb. For some applicationsindicator light 248 may be activated when ninety percent (90%) ofelectrical storage capacity of battery pack 216 has been used.

The configuration and dimensions of an intraosseous device formed inaccordance with teachings of the present disclosure may vary dependingupon respective intended applications for each intraosseous device. Forexample, the length of a vertebral IO needle formed in accordance withteachings of the present disclosure may vary from approximately about 5inches to about 10 inches. In one non-limiting example a vertebral IOneedle may be about 6 inches (or 152 millimeters). However, vertebralneedles with other lengths may also be made in accordance with theteachings of this disclosure.

The length of a biopsy needle formed in accordance with teachings of thepresent disclosure may vary from approximately five (5) millimeters tothirty (30) millimeters. However, biopsy needles having other lengthsmay also be formed in accordance with teachings of the presentdisclosure.

Aspiration needles formed in accordance with teachings of the presentdisclosure may have lengths of approximately twenty five (25)millimeters, sixty (60) millimeters and ninety (90) millimeters. Forsome applications an aspiration needle having a length of ninety (90)millimeters or more may also include one or more side ports. See forexample FIGS. 6A-6C.

Further details about IO biopsy systems and needle sets and IOaspirations systems may be found in co-pending U.S. patent applicationSer. No. 11/853,678 filed on Sep. 11, 2007 (073252.0204).

Intraosseous (IO) devices formed in accordance with teachings of thepresent disclosure may have outside diameters and longitudinal bores orlumens corresponding generally with eighteen (18) gauge to ten (10)gauge needles. For example, a vertebral IO needle may have a cannulawith an eight (8) gauge to eleven (11) gauge diameter while an biopsyneedle that may be inserted inside the vertebral cannula may have adiameter of fifteen (15) gauge to sixteen (16) gauge. The configurationand dimensions of each IO device may depend upon the size of anassociated bone and desired depth of penetration of associated bonemarrow. In one specific non-limiting example, a vertebral IO needle setmay comprise a beveled cutting tip and a stylet and may be an 11 gauge,152 millimeter needle, made of 304 stainless steel.

Combining a powered driver with a coupler assembly and a vertebralneedle set in accordance with teachings of the present disclosure mayallow rapid access to the vertebral or spinal bones or other insertionsites. Vertebral access systems incorporating teachings of the presentdisclosure may be capable of inserting a vertebral needle to a desireddepth in cancellous bone in ten (10) to fifteen (15) seconds. This samecapability may be used to obtain bone marrow using the bone marrowaspiration systems as well as biopsy specimen of bone and/or bone marrowusing the biopsy needles of the present disclosure.

Intraosseous (IO) needle sets, such as vertebral IO needles 100 a and100 b, biopsy needles 100 c and 100 d and aspiration needle 100 e asshown in FIGS. 1A-1B and/or FIGS. 6A-6C represent only some examples ofintraosseous devices formed in accordance with teachings of the presentdisclosure. All the IO needles may have similar outer penetrators orcannulas 110 a and similar inner penetrators to stylets 120. See FIGS.6A-6C. Similar or different hub assemblies 130 or 130 a may be used.

For embodiments represented by IO needle sets 100 and 100 a, first end111 a of cannula 110 a and first end 121 of stylet 120 may be operableto penetrate a bone and/or associated bone marrow. Various features offirst end 111 a of cannula 110 a and first end 121 of stylet 120 areshown in more detail in FIGS. 7A-7F. First end 101 of IO needle sets 100and 100 a may correspond generally with first end 111 a of cannula 110 aand first end 121 of stylet 120.

Cannula 110 a may have a plurality of markings 104 disposed on exteriorportions thereof Markings 104 may sometimes be referred to as“positioning marks” or “depth indicators.” Markings 104 may be used toindicate the depth of penetration of the IO needle set 100 or 100 a intoa bone (e.g. vertebral bone) and/or associated bone marrow. For someapplications cannula 110 a may have a length of approximately sixty (60)millimeters and may have a nominal outside diameter of approximately0.017 inches corresponding generally with a sixteen (16) gauge needle.In some applications, a cannula 110 a may be an 8-11 gauge needle and aninner trocar such as a biopsy or cement trocar may be a 15-16 gaugeneedle. Cannula 110 a may be formed from stainless steel or othersuitable biocompatible materials. Positioning marks 104 may be spacedapproximately one (1) centimeter from each other on exterior portions ofcannula 110 a.

Hub assembly 130 as shown in FIGS. 6A-6C may be used to releasablydispose stylet 120 within longitudinal bore or lumen 118 of cannula 110a. Hub assembly 130 may include first hub 140 and second hub 150. Thesecond end of cannula 110 a, opposite from first end 111 a, may besecurely engaged with the second end of cannula 110 a. The second end ofstylet 120, opposite from first end 121, may be securely engaged withthe first end of hub 150.

As shown in FIG. 6A cannula 110 a may extend longitudinally from firstend 141 of hub 140. Stylet 120 may also extend from the first end of hub150 (not expressly shown). The second end of hub 140 may include astandard Luer lock fitting which may be releasably engaged with acorresponding Luer lock fitting disposed within the first end of secondhub 150. Threaded connections may be present between the second end offirst hub 140 and the first end of second hub 150 (not expressly shown).Examples of Luer lock connections and/or fittings are shown in moredetail in FIGS. 6A-6C. The Luer lock fitting disposed on the second endof hub 140 may be operable to be releasably engaged with a standardsyringe type fitting and/or a standard intravenous (IV) connection.

Hub 150 includes second end 152 which generally corresponds with secondend 132 of hub assembly 130 and second end 102 of IO needle set 100. Hub140 may include first end 141 which may generally correspond with firstend 131 of hub assembly 130. Cannula 110 a may extend longitudinallyfrom first end 141 of hub 140 and first end 131 of hub assembly 130.

Various types of receptacles may be satisfactory disposed in second end152 of hub 150 for use in releasably engaging hub assembly 130 with apowered driver. For example, a receptacle having a generally taperedconfiguration corresponding with the tapered configuration of one end ofa drive shaft extending from a powered driver may be releasably engagedwith second end 152 of hub 150. Powered driver 200 as shown in FIGS.4A-4C may represent one example of a powered driver having a drive shaftextending from a housing with a tapered portion operable to bereleasably engaged with a receptacle having a corresponding generallytapered configuration. For some applications such powered drivers may besecured to an intraosseous device by a magnet (not expressly shown)disposed on the end of the tapered shaft extending from the powereddriver and a metal disk disposed within a corresponding receptacle inthe intraosseous devices. Such powered drivers may also be used withintraosseous devices used to obtain emergency vascular access (EVA).

The coupler assembly as depicted in FIGS. 5A and 5B depicts howcontainment bag 170 is attached to the coupler. Containment bag 170 isattached proximate end 252 of the coupler. In some embodiments, thecontainment bag may be attached using a hot glue gun. However, a widevariety of attachment mechanisms such as but not limited to couplerassemblies, port assemblies, connectors, receptacles, fittings, hubs,hub assemblies, latching mechanisms and/or other types of connectingdevices incorporating teachings of the present disclosure may besatisfactorily used to attach the container bag with the couplerassembly.

A “tortuous path” 14 is defined proximate attachment of bag 170 and thebody of the coupler. A tortuous path 14 may be a non-linear path suchthat bodily fluids that may contain bacteria, viruses or other pathogenscannot easily traverse to cause contamination of a sterile IO deviceattached at end 251 of the coupler. A tortuous path may comprise sharpcurves. If a pathogen falls into a part of the tortuous path the sharpcurves and edges prevent the pathogen from reaching sterile surfaces onthe other side.

For other embodiments, the second end of a hub assembly may be operableto be disposed within a receptacle formed in a coupler assemblyincorporating teachings of the present disclosure. One feature of thepresent disclosure may include forming a hub assembly which may bereleasably engaged within a first receptacle disposed in a first end 251of a coupler assembly 250. See for example receptacle 263 proximatefirst end 261 of elongated core 260 as shown in FIG. 5A-5D. Thedimensions and configuration of receptacle 263 may be selected toprevent rotation of hub 150 a relative to hub 140 a while inserting(rotating) an IO device into a bone and associated bone marrow. Thepowered driver may be releasably engaged with a second receptacledisposed in a second end 252 of the coupler assembly. See for examplereceptacle 264 proximate second end 262 of elongated core 260 as shownin FIGS. 5A-5B.

At least one portion of hub assembly 130 a may have a generallyhexagonal cross section operable to be received within the generallyhexagonal cross section of receptacle 264 disposed proximate first end251 of coupler assembly 250. See FIGS. 5C and 5D. For some embodimentsportions of first hub 140 a disposed adjacent to reduced outsidediameter portion 143 may have generally hexagonal cross sections. SeeFIGS. 6A and 6B. Various cross sections other than hexagonal may besatisfactorily used to releasably engage a powered driver with one endof a coupler assembly and an intraosseous device with an opposite end ofthe coupler assembly.

Aspiration needle sets may often include a trocar, stylet or penetratorin combination with an associated cannula, catheter or outer penetrator.However, biopsy needles formed in accordance with teachings of thepresent disclosure may or may not include a trocar, stylet or innerpenetrator. For example, biopsy needle 100 c is shown in FIG. 6Battached to first end of hub 140 a. A stylet or inner penetrator is notattached to first end 151 of hub 150 a.

For embodiments represented by biopsy needle 100 c, hub 140 a may beused to releasably engage biopsy needle 100 c in a receptacle formed ina coupler assembly incorporating teachings of the present disclosure.Hub 150 a may be attached to close of end 141 of hub 140 a. However, formany applications hub 140 a without hub 150 a may be connected with oneend of a coupler assembly in accordance with teachings of the presentdisclosure. Biopsy needle 100 c may be used to capture a biopsy specimenof a bone and associated bone marrow. Placing a trocar within biopsyneedle 100 c may result in substantial damage to the bone specimenduring penetration of the bone by the combined tips of the trocar andbiopsy needle 100 c.

Hub 140 a may include second end 142 with opening 144 formed therein.Passageway 146 may extend from second end 142 towards first end 141 ofhub 140 a. Passageway 146 may be operable to communicate fluids withlumen 118 of cannula 100 a. See FIGS. 6A-6C and FIGS. 7A-7F. Second end142 of hub 140 may include various features of a conventional Luer lockconnection or fitting, including threads 148. Corresponding threads 158may be formed within first end 151 of hub 150 a. The dimensions andconfiguration of receptacle 263 in first end 251 of coupler assembly 250may be selected to prevent relative movement between hub 140 a and hub150 a during insertion (rotation) of an IO device into a bone andassociated bone marrow. If such relative movement occurs, threads 148and 158 may be disconnected.

For some applications hub 140 a and hub 150 a may be formed usinginjection molding techniques. For such embodiments hub 140 a may includereduced outside diameter portion 143 disposed between first end 141 andsecond end 142. In a similar manner a plurality of void spaces orcutouts 153 may be formed in hub 150 a adjacent to and extending fromsecond end 152 in the direction of first end 151. See for example FIGS.6A, 6B and 4A. The configuration and dimensions of reduced diameterportion 143 and/or cutouts 153 may be varied to optimize associatedinjection molding techniques and at the same time provide requiredconfigurations, dimensions and material strength to allow associated hubassembly 130 a to function in accordance with teachings of the presentdisclosure.

FIGS. 7A and 7B show one example of cutting surfaces and tips which maybe formed adjacent to the ends of a cannula and an associated trocar inaccordance with teachings of the present disclosure. For embodimentsrepresented by cannula or outer penetrator 110 a and trocar or innerpenetrator 120 a, tip 123 of stylet 120 may be disposed relatively closeto tip 113 of cannula 110 a. For some applications, first end 121 oftrocar 120 and first end 111 a of cannula 110 a may be ground at thesame time to form adjacent cutting surfaces 114 and 124. Grinding ends111 a and 121 at the same time may result in forming a single cuttingunit to form generally matching cutting edges 124 e and 114 e such asshown in FIGS. 7A and 7B. Beveled cutting surfaced and/or serratedcutting surfaces may be used in some embodiments. Other types of cuttingsurfaces formed in accordance with teachings of the present disclosuremay be discussed later.

First end 121 of trocar 120 may extend through opening 144 in second end142 of hub 140 a. See FIG. 6A. Hub 150 a disposed on the second end oftrocar 120 may be releasably engaged with the second end of cannula 110a represented by hub 140 a. See FIG. 6B.

Human bones may generally be described as having a hard outer lamellaeor layer of osseous tissue known as “cortical bone”. Cancellous bone(also known as trabecular or spongy bone) typically fills an innercavity associated with cortical bone. Cancellous bone is another type ofosseous tissue with generally low density and strength but high surfacearea. Cancellous bone typically includes spicules or trabeculae whichform a latticework of interstices filled with connective tissue or bonemarrow. Exterior portions of cancellous bone generally contain red bonemarrow which produces blood cellular components. Most of the arteriesand veins of a bone are located in the associated cancellous bone.

One of the benefits of the present disclosure may include providingvarious vertebral intraosseous devices including, but not limited to,vertebroplasty needles, vertebral biopsy needle sets configured toreliably provide a therapeutic agent and adapted to obtain biopsyspecimens of cortical bone and/or cancellous bone by reducing need formultiple procedures/insertions in a patient.

The configuration of the tip of a cannula or outer penetrator may bemodified in accordance with teachings of the present disclosure toprovide optimum torque during insertion of the cannula or outerpenetrator by a powered driver to penetrate bone for a therapeutic ordiagnostic procedure. A controlled, steady feed rate when using apowered driver may result in higher quality delivery of therapeuticagent (cement) and/or obtaining biopsy specimens as compared to manuallyinserted IO needles. A needle comprising a beveled cutting tip, such asa stylet may be used to initially penetrate bone. The cutting tip may beretractable and withdrawn after insertion of a cannula comprising thebeveled cutting tip. A rod shaped needle/cannula, containing one or moretherapeutic agents (such as but not limited to a bone cement),configured to inject the therapeutic agent, may be disposed within thehollow cannula that has a tip making contact with the interior of thebone. In embodiments wherein a biopsy sample is desired, a biopsyrod/trocar may also be inserted into the hollow cannula. A biopsy rodmay have a helical thread disposed within proximate an associate tip orfirst end to assist with capturing a bone and/or bone marrow biopsyspecimen.

The quality and reliability of a medical procedure incorporatingteachings of the present disclosure may be substantially improved byusing an optimum feed rate for inserting and IO needle into a bone andassociated bone marrow. Feed rate or speed of insertion of an IO biopsyneedle incorporating teachings of the present disclosure may be afunction of the pitch of at least one thread disposed on an interiorportion of the biopsy needle and revolutions per minute (RPM) of thebiopsy needle.

RPM=Feed rate×Pitch of threads

Helical thread 190 as shown in FIGS. 8A-8D may have a pitch ofapproximately twenty four (24) threads per inch. An optimum pitch mayvary based on factors such as reduction gear ratio (77:1 for someembodiments) and load placed on an associated motor.

Further technical benefits may include reducing physical requirementsand mental stress on users and decreasing pain and stress on patients byincreasing speed and control of the needle set insertion duringvertebral procedures or other bone procedures and by decreasing thenumber of procedures performed and the number of times a bone is drilledinto.

For some applications, an IO needle formed in accordance with teachingsof the present disclosure may include a hollow cannula or catheterhaving one end formed by electrical discharge machining (EDM)techniques, grinding techniques and/or other machining techniques. Aplurality of teeth may be formed on one end of the cannula or catheterusing EDM techniques, grinding techniques and/or other machiningtechniques.

For some embodiments a stylet or trocar may also be disposed within thecannula or catheter with a first end of the stylet extending from afirst end of the cannula or catheter. Increasing the length of the firstend of the stylet or trocar extending from the first end of the cannulaor catheter may reduce the amount of torque or force required topenetrate a bone and may reduce time required for an associated IOneedle set, vertebral needle set, biopsy needle set, aspiration needleset or to penetrate the bone and associated bone marrow.

A specific powered driver, intraosseous device and tip configurationwill generally produce the same torque when drilling in a hard bone or asoft bone. However, the time required to drill to a first depth in ahard bone will generally be greater than the time required to drill tosimilar depth in a soft bone.

For still other embodiments, teeth formed on one end of a cannula orcatheter may be bent radially outward to reduce the amount of timeand/or force required to penetrate a bone and associated bone marrowusing the cannula or catheter. For some applications a powered driverand vertebral needle set, aspiration needle set or biopsy needle setformed in accordance with teachings of the present disclosure mayprovide access to a patient's bone using a similar amount of torque. Thelength of time for penetrating a relatively hard bone may be increasedas compared with the length of time required to penetrate a relativelysofter bone.

The tips of several stylets and cannulas incorporating teachings of thepresent disclosure were slowly ground with coolant to prevent possiblethermal damage to metal alloys or spring material used to form thestylets and cannulas. The stylets and cannulas were assembled intorespective IO needle sets. The tips of each needle set were insertedinto sawbones blocks under controlled test conditions. Some testing wasconducted with Pacific Research sawbones blocks. The tips of the needlesets were inserted to a depth of approximately two centimeters with tenpounds (10 lbs) of force and twelve volts direct current (12 VDC)applied to an associated powered driver. There was no measurable orvisual wear of the stylet or cannula tips after completion of thetesting.

For some embodiments a generally hollow biopsy needle may besubstantially continuously rotated at an optimum speed or RPM duringinsertion into a selected target area to obtain a biopsy specimen. Thebiopsy needle may include a longitudinal bore extending from a first,open end of the needle to a second, open end of the needle. A smallhelical thread may be formed on interior portions of the longitudinalbore proximate the first end. For some embodiments the thread may have apitch similar to threads used on conventional wood screws. The rate ofrotation or revolutions per minute (RPM) of the biopsy needle may beselected by installing a gear assembly with a desired speed reductionratio (typically between 60:1 and 80:1) between a motor and anassociated drive shaft. For some applications the gear assembly mayreduce speed of rotation of an attached motor at a ratio ofapproximately 66:1 or 77:1.

Outer penetrator or cannula 110 f as shown in FIG. 7C may include firstend 111 f having a plurality of cutting surfaces 114 f formed adjacentto opening 116 in first end 111 f. Opening 116 may communicate with andform a portion of an associated longitudinal bore or lumen 118. For someapplications cutting surfaces 114 f may be formed using electricaldischarge machining (EDM) techniques.

Cannula 110 f as shown in FIG. 7C may have a cutting surface or tooth114 f protruding outward followed by the next cutting surface or tooth114 f protruding inward resulting in a cross-cut saw-type pattern. Forsome medical applications, a cannula such as 110 f may be usedeffectively. The pattern of the cutting surfaces may be effective toobtain a biopsy sample since the teeth extending outward may form apassageway (not expressly shown) with an inside diameter larger than acorresponding outside diameter of the cannula. The teeth extendinginward may form a sample of bone and/or bone marrow (not expresslyshown), having a generally cylindrical configuration with an outsidediameter smaller than a corresponding inside diameter of the cannula.The result of such “cross cutting” may be less friction between exteriorportions of the cannula and adjacent bone and/or bone marrow and lessdamage to a biopsy sample disposed within the lumen of the cannula.

For embodiments such as shown in FIG. 7D, outer penetrator or cannula110 g may include first end 111 g having a generally taperedconfiguration or reduced outside diameter as compared with otherportions of cannula 110 g. A plurality of cutting surfaces 114 g may bedisposed on end 111 g adjacent to respective opening 116. For someapplications, cutting surfaces 114 g may be formed using machinegrinding techniques. For embodiments end 111 g of cannula 110 g mayinclude six ground cutting surfaces 114 g with respective crowns 115 maybe formed therebetween. Forming a biopsy needle set and/or biopsy needlewith tapered end 111 g and a plurality of cutting surfaces 114 g andcrowns 115 may provide improved drilling performance when the resultingbiopsy needle set and/or biopsy needle is used with a powered driver inaccordance with teachings of the present disclosure.

For some applications, helical groove 117 may be formed withinlongitudinal bore 118 proximate respective opening 116. Helical groove117 may assist with retaining a biopsy specimen or a bone marrowspecimen within longitudinal bore 118.

Testing conducted with cannulas or outer penetrators formed inaccordance with teachings of the present disclosure indicated thatforming cutting surfaces or cutting teeth with electrical dischargemachining (EDM) sometimes resulted in the associated cannula or outerpenetrator being able to drill through a bone and associated bone marrowslightly faster than a cannula or outer penetrator having cuttingsurfaces formed using grinding techniques. Some test results alsoindicated that bending cutting surfaces formed on one end of a cannulaor outer penetrator in accordance with teachings of the presentdisclosure may reduce the amount of time and/or the amount of forcerequired to remove a bone and/or bone marrow specimen from a targetarea.

Intraosseous needle set or biopsy needle set 100 g is shown in FIGS. 7Eand 7F. Biopsy needle set 100 g may include cannula or outer penetrator110 g with stylet or inner penetrator 120 g slidably disposed therein.First end 101 of biopsy needle set 100 g is shown in FIGS. 7E and 7F.For some applications first end 101 of biopsy needle set 100 g mayminimize damage to skin and soft body tissue at an insertion site.

For some applications inner penetrator or trocar 120 g may include firstend 121 having a plurality of cutting surfaces 125 and 126 formed onexterior portions thereof extending from associated tip 123 towardssecond end of trocar or inner penetrator 120 g. For some applicationsone or more cutting surfaces 125 may be formed having length 127extending from tip 123 to associated cutting surfaces 114 g inassociated cannula 110 g. One or more cutting surfaces 126 may be formedadjacent to each cutting surface 125 with second length 128. Firstlength 127 may be greater than second length 128. The ratio of firstlength 127 and second length 128 may be varied in accordance withteachings of the present disclosure to provide optimum performance forpenetrating a selected bone and associated bone marrow.

For some applications, a single thread may be disposed within thelongitudinal bore or lumen of a biopsy needle, cannula, catheter orouter penetrator in accordance with teachings of the present disclosure.Various techniques and procedures may be satisfactorily used to placethe single thread within a generally hollow cannula or outer penetratorproximate one end of the cannula or outer penetrator having one endoperable to penetrate a bone and/or associated bone marrow. For someembodiments, a helical coil having a configuration and dimensionsassociated with the resulting single thread may be placed on one end ofa mandrel such as a spot welding electrode assembly. The mandrel orelectrode assembly may then be inserted through an opening in the oneend of the cannula or outer penetrator operable to penetrate a boneand/or associated bone marrow. The helical coil may then be bonded withadjacent portions of cannula. Coils having a wide variety of dimensionsand configurations may be satisfactorily used to place a single threadin a biopsy needle.

For embodiments such as shown in FIGS. 8A-8E, examples of helicalthreads are shown disposed in biopsy needles or cannulas incorporatingteachings of the present disclosure. Outer penetrator or cannula 110 has shown in FIG. 8A may be formed with longitudinal bore 118 or lumen118 extending from open 116 through cannula 110 h. Electrode assembly ormandrel 160 may be used to install (spot weld) a single helical threadin lumen 118 proximate opening 116.

Helical coil 192 as shown in FIG. 8B may be placed on first end 161 ofelectrode assembly 160. Helical coil 192 may have the cross section of aright triangle. First end or copper electrode 161 may have anappropriate configuration and dimensions to be slidably received withinopening 116 formed in first end 111 of cannula or outer penetrator 110h. First end or copper electrode 161 of mandrel 160 may includecorresponding groove 164 with a configuration and dimensionssatisfactory to receive helical coil 192 therein. Groove 164 may beformed with a desired pitch for resulting thread 190 when attached to orbonded with interior portions of cannula 110 h.

For some applications electrode assembly 160 may include enlargedoutside diameter portion or plastic insulator 194 disposed adjacent tofirst end 161. The dimensions and/or configuration of copper electrode161 and plastic insulator 194 may be selected to accommodate installinghelical coil 192 at an optimum location relative to end 116 forretaining biopsy specimens in lumen 118. For example, the dimensions andconfiguration of plastic insulator 194 may be selected to contact theextreme end of outer penetrator or cannula 110 h proximate crowns 115.

Copper electrode 161 of electrode assembly 160 with helical coil 192attached thereto may be inserted into opening 116 in first end 111 h ofcannula 110 h. Electrode assembly 160 may be operable to conductelectricity to copper electrode 161 to accommodate spot welding helicalcoil 192 with adjacent interior portions of longitudinal bore 118 ofcannula 110 h. For some embodiments mandrel 160 may be formed frommaterials compatible with laser welding helical coil 192 with interiorportions of lumen or longitudinal bore 118 of cannula 110 h. Whenattached to interior portions of a cannula or outer penetrator 110 h,helical coil 192 may form a single thread having shoulder 191 extendinggenerally perpendicular to adjacent interior portions of lumen 118. Theresulting dimensions and configuration of helical thread 190 may beselected to optimize retaining a specimen of bone and/or bone marrow onshoulder 191 of thread 190 within lumen 118.

Cannula 110 c of biopsy needle 100 c is shown in FIG. 8C with helicalthread 190 disposed therein. The combination of helical thread 190 withshoulder 191 extending substantially perpendicular to interior portionsof lumen 118 may increase the reliability of biopsy needle 100 c toretain a specimen of bone and/or bone marrow. For some applicationscombining helical thread 190 with cutting surfaces 114 and crowns 115may substantially increase the reliability of obtaining a satisfactorybone specimen when using biopsy needle 100 c with a powered driver inaccordance with teachings of the present disclosure.

Helical thread 190 may be positioned at an optimum location relative toopening 116 in cannula 110 c to begin capture of a bone marrow specimenor cancellous bone core. By inserting biopsy needle 100 c at an optimumfeed corresponding with the pitch of helical thread 190, helical thread190 may be “screwed in” cancellous bone entering opening 116 tosubstantially increase the probability of capturing a satisfactorybiopsy specimen or bone marrow core.

For embodiments such as shown in FIG. 8D cannula or outer penetrator 110d may include first end 111 d having a plurality of exterior cuttingsurfaces 114 d formed thereon and extending therefrom. The length ofcutting surfaces 114 d may be longer than the length of correspondingcutting surfaces 114. Respective crowns 115 d may be formed betweenadjacent cutting surfaces 114 d and 114 g.

For some applications a helical thread having a generally “wedge shaped”cross section similar to an equilateral triangle may be disposed withinthe longitudinal bore or lumen of an outer penetrator or cannulaincorporating teachings of the present disclosure. For example cannula110 d may include helical thread 190 a having a generally wedge shapedcross section corresponding approximately with an equilateral triangle.Helical thread 190 a may be installed within cannula 110 d usingapparatus and procedures as previously described with respect to helicalthread 190.

FIG. 8E shows an example of combining inner penetrator or stylet 120 cwith cannula or outer penetrator 110 c having helical thread 190disposed therein to form biopsy needle set 100 c in accordance withteachings of the present disclosure. Biopsy needle 100 c is shown inFIGS. 6B and 8C without a stylet or trocar. Biopsy needle set 100 c isshown in FIG. 8E with trocar or stylet 120 c disposed in cannula 110 c.Trocar 120 c may include end 121 c with a pair of cutting surfaces 125and a pair of cutting surface 126 as shown in FIG. 7F. Surfaces 125 and126 may cooperate with each other to form a cutting tip on trocar orstylet 120 c similar to a “chisel point” drill bit. The pair of cuttingsurfaces 125 may be offset (relief angle) approximately eight degreesrelative to the pair of cutting surfaces 126. The included angle ofcutting surfaces 125 may be approximately thirty four degrees (34°) plusor minus four degrees (±4°). The included angle of cutting surfaces 126may be approximately sixteen degrees (16°) plus or minus three degrees(±3°).

For some applications end 121 of trocar 120 c may extend from end 111 cof cannula 110 c with respective cutting surfaces 114 of cannula 110 gdisposed adjacent to the end of each cutting surface 126 (short cuttingsurface) opposite from tip 123 of trocar 120 c. See FIG. 8E. As a resultportions of each cutting surface 125 (long cutting surface) of trocar120 c may be disposed within end 111 of cannula 110 c. See FIG. 8E.

Placing portions of cutting surfaces 125 within end 111 of cannula 110 cmay result in more uniform forces being applied to end 101 ofintraosseous device 100 c while penetrating the cortex of an associatedbone using biopsy needle set 100 c and a powered driver in accordancewith teachings of the present disclosure. When the cortex has beenpenetrated, forces applied to end 101 of biopsy needle set 100 c maydecrease sufficiently to indicate that end 101 has now enteredassociated bone marrow. An operator may then withdraw trocar 120 c fromcannula 110 c and position end 111 c of cannula 110 c at a desiredtarget area to perform a bone marrow biopsy.

For some embodiments threads 190 and 190 a may extend approximately0.005 inch from adjacent portions of an associated longitudinal bore orlumen 118. The outside diameter of an associated trocar such as trocar120 c as shown in FIG. 8E may be reduced to accommodate the height ofthread 190 or 190 a. The following test results were obtained duringinsertion of intraosseous devices such as biopsy needle set 100 c shownin FIG. 8E into sawbones material or blocks with three millimeters (3mm) of fifty pound (50#) and forty millimeters (40 mm) of forty pound(40#) material.

Test # Motor Torque(g-cm) Time(s) 44 1101 2.23 45 1081 2.49 46 1071 2.3647 1081 2.50 48 1030 2.46 49 1070 2.33 Average 1072 2.40

The distance between the end of cutting surface 126 or trocar 120 c andadjacent cutting surface 114 on cannula 110 c was approximately 0.14inches. End 111 of cannula 110 c had six (6) ground cutting surfaces114. The outside diameter of trocar 120 c was approximately 0.086inches.

Coupler assemblies incorporating teachings of the present disclosure mayfunction as “quick release mechanisms” operable to engage and disengagean IO device from a powered driver disposed within a flexiblecontainment bag or sterile sleeve. Such coupler assemblies may allowrotation of an IO device without damage to the flexible containment bagor sterile sleeve. For some applications the IO device may be avertebral IO needle or a biopsy needle. One end of the coupler assemblymay be operable to form a fluid seal or fluid barrier with adjacentportions of the containment bag or sterile sleeve. A coupler assemblyincorporating teachings of the present disclosure may be used in“non-sterile” environments and/or medical procedures which do notrequire the use of a containment bag or sterile sleeve.

Coupler assemblies incorporating various teachings of the presentdisclosure may be placed in a medical procedure tray or kit with one enddown and an opposite end looking up to allow “hands free” releasableengagement with a powered driver or a manual driver. For example,coupler assembly 250 may be disposed in medical procedure tray 20 c withfirst end 251 insert into holders 58 and second end 252 looking up. SeeFIGS. 1C and 1D. As a result, end 224 of drive shaft 222 extending frompowered driver 200 may be inserted into and releasably engaged withsecond end 252 of coupler assembly 250 without requiring an operator oruser (not expressly shown) to physically contact or manipulate anyportion of coupler assembly 250. Various features of associated “handsfree” latching mechanisms are depicted in FIGS. 5A-5B.

As shown in FIGS. 5A-5D, coupler assembly 250 may include elongated core260 with housing assembly 270 slidably disposed on exterior portions ofelongated core 260. Housing assembly 270 may include first end 271 andsecond end 272 which may be generally aligned with respective first end261 and respective second end 262 of elongated core 260. For someapplications, elongated core 260 may have a generally cylindricalconfiguration defined in first exterior portion 260 a and secondexterior portion 260 b with various shoulders and/or recesses formedthereon. For some embodiments first exterior portion 260 a may have alarger diameter than second exterior portion 260 b.

Coupler assembly 250 a and coupler assembly 250 b may include respectiveelongated cores 260 a and 260 b having similar features and functions asdescribed with respect to coupler assembly 250. Coupler assembly 250 amay include housing assembly 270 a with substantially the samecomponents, functions and features as described with respect to housingassembly 270 except for second end 272 a of housing assembly 270 a.Coupler assembly 250 b may include housing assembly 270 b havingsubstantially similar components, functions and features as describedwith respect to housing assembly 270 except for second end 272 b ofhousing assembly 270 b.

Housing assembly 270 may be described as having a generally hollow,cylindrical configuration defined in part by first housing segment 280and second housing segment 290. See FIGS. 5A and 5B. The first end ofhousing segment 280 may generally correspond with first end 271 ofhousing assembly 270. The second end of second housing segment 290 maygenerally correspond with second end 272 of housing assembly 270.

First end 291 of second housing segment 290 may be described as having agenerally cylindrical configuration with an outside diameter smallerthan the adjacent inside diameter of second end 282 of first housingsegment 280. First end 291 of second housing segment 290 may slidelongitudinally from a first position to a second position within secondend 282 of first housing segment 280 to release one end of a drive shaftengaged with second end 252 of coupler assembly 250 (See FIGS. 5A-5D).

A biasing mechanism such as coiled spring 274 may be disposed aroundexterior portion 260 a of generally elongated core 260. See for exampleFIGS. 5A, 5B, 5C and 5D. First end 275 of coiled spring 274 may contactannular shoulder 284 formed on interior portions of first housingsegment 280. Second end 276 of coiled spring 274 may contact annularshoulder 278 disposed proximate first end 291 of second housing segment290. Coil spring 274, annular shoulder 284 and annular shoulder 278 maycooperate with each other to generally maintain first housing segment280 and second housing segment 290 in a first extended position relativeto each other. See FIGS. 4A and 5A-5D. Other biasing mechanisms such as,but not limited to, leaf springs and bellows (not expressly shown) mayalso be disposed between annular shoulder 284 and annular shoulder 278.

Annular shoulder 278, associated with second end 276 of coiled spring274, may extend radially outward from generally cylindrical ring 277.Generally cylindrical ring 277 may be slidably and rotatably disposed onexterior portion 260 a of elongated core 260. Annular shoulder 279 maybe disposed on interior portions of generally cylindrical ring 277 andmay extend radially inward toward adjacent portions of elongated core260.

Annular shoulder 268 may be formed on exterior portion 260 a ofelongated core 260 intermediate first end 261 and second end 262. Theconfiguration and dimensions of annular shoulder 268 and annularshoulder 279 are selected to be compatible with each other such thatengagement between annular shoulder 279 of generally cylindrical ring277 with annular shoulder 268 of elongated core 260 may limit movementof second housing segment 290 longitudinally in the direction of secondend 262 of elongated core 260.

For some applications a plurality of flexible collets or fingers 477 mayextend from generally cylindrical ring 277 opposite from annularshoulder 278. Respective collet heads 478 may be formed on the end ofeach collet 477 opposite from annular shoulder 278. The dimensions andconfiguration of collet heads 478 may be selected to be received withinrespective slots or openings 297 formed in second housing 290. Duringmanufacture of coupler assembly 250, each collet head 478 may bedisposed within respective slot or opening 297 to securely engagegenerally cylindrical ring 277 and annular shoulder 278 proximate firstend 291 of second housing segment 290. As a result, second housingsegment 290 and annular shoulder 278 may generally move as a single unitrelative to elongated core 260 and first housing segment 280.

During disengagement of an intraosseous device from first end 251 ofcoupler assembly 250, first housing segment 280 may move or slidelongitudinally toward second housing segment 290. In a similar manner,second housing segment 290 may move or slide longitudinally toward firsthousing segment 280 during disengagement of a powered driver from secondend 252 of coupler assembly 250.

Annular shoulder 267 may be formed on exterior portions of elongatedcore 260 proximate first end 261. Annular shoulder 267 may engageportions of first end 271 of housing 270 to limit longitudinal movementof first housing segment 280 during longitudinal movement of secondhousing segment 290 towards first end 261 of elongated core 260 duringdisengagement of a powered driver from second end 252 of couplerassembly 250.

As previously noted, annular shoulder 268 may be formed on exteriorportions of elongated core 260 between first end 261 and second end 262.Engagement between annular shoulder 268 and annular shoulder 279 ofgenerally cylindrical ring 277 may limit movement of second housingsegment 290 toward second end 262 of elongated core 260. Contact betweenspring 274 and annular shoulder 278 and annular shoulder 284 of firsthousing segment 280 may limit the longitudinal movement of first housingsegment 280 in the direction of second end 262 of elongated core 260during disengagement of an intraosseous device from first end 251 ofcoupler assembly 250.

Generally cylindrical ring 277 and attached annular shoulder 279 mayslide longitudinally on exterior portions of annular core 260 betweenannual shoulder 268 and annular shoulder 267. First housing segment 280may move longitudinally toward second end 262 of elongated core 260 torelease one end of intraosseous device from engagement with first end251 of coupler assembly 250. In a similar manner, second housing segment290 may move longitudinally toward first end 261 of elongated core 260to release one end of a drive shaft extending from a powered driverengaged with second end 252 of coupler assembly 250.

A wide variety of latches and latch mechanisms may be satisfactorilyused to releasably engage one end of an intraosseous device within afirst end of a coupler assembly incorporating teachings of the presentdisclosure. In a similar manner, a wide variety of latches and latchmechanisms may be satisfactorily used to releasably engage one end of adrive shaft extending from a powered driver or manual driver within asecond end of the coupler assembly incorporating teachings of thepresent disclosure.

For embodiments represented by coupler assemblies 250, 250 a and 250 b,first latch 410 may be disposed on exterior portions of elongated core260 proximate receptacle 263 adjacent to first end 261 to releasablyengage one end of an IO device such as second end 102 of an IO needleset 100 within receptacle 263 of coupler assembly 250, 250 a and/or 250b. Second latch mechanism 420 may be disposed on exterior portions ofelongated core 260 proximate receptacle 264 adjacent to second end 262to releasably engage one end of a drive shaft with second end 252 ofcoupler assembly 250. See FIGS. 4A-4C and FIGS. 5A-5D.

Second latch 420 may be used to releasably engage one portion of a driveshaft such as end 224 of drive shaft 222 extending from powered driver200 within second end 252 of coupler assembly 250, 250 a and/or 250 b.Latch 410 may releasably engage an intraosseous device with first end251 of coupler assembly 250 substantially the same latch 420 mayreleasably engage a powered driver with second end 252 of couplerassembly 250.

For some applications, latches 410 and 420 may have similarconfigurations such as a general “omega” shape. See latch 420 in FIGS.5C and 5D. However, latch 410 may have larger dimensions correspondinggenerally with exterior portion 260 a of elongated core 260. Latch 420may have smaller dimensions corresponding generally with exteriorportion 260 b of elongated core 260. Various features of the presentdisclosure may be described with respect to latch mechanism 420 as shownin FIGS. 5C and 5D along with adjacent portions of second housingsegment 290 and exterior portion 260 b of elongated core 260.

Respective detents 421 and 422 may be formed on opposite ends ofgenerally omega shaped latch 420. See FIGS. 5C and 5D. In a similarmanner, respective detents (not expressly shown) may be formed on theends of generally omega shaped latch 410. The configuration anddimensions of detents 421 and 422 may be compatible with placing eachdetent 421 and 422 in respective slot or opening 431 and 432 extendingbetween exterior portion 260 b of elongated core 260 to interiorportions of receptacle 264 disposed proximate second end 252 of couplerassembly 250.

Latch 420 may have a first position such as shown in FIGS. 5A-5D inwhich portions of detents 421 and 422 may extend through respectiveslots 431 and 432. The dimensions and configuration of detent 421 and422 may be operable to be securely engaged with annular groove 402formed in end 224 of powered driver 200. In a similar manner, respectivedetents on associated latch 410 may be releasably engaged with annulargroove 401 disposed in second end 102 of an IO needle 100.

For some applications, a plurality of tapered surfaces 403 may be formedon exterior portions of hub 140 a proximate first end 142 (See FIG. 5A)to radially expand detent mechanisms associated with omega shaped latch410 radially outward while inserting second end 102 of biopsy needle 100b into first end 251 of coupler assembly 250, 250 a or 250 b. The detentmechanism may “snap” into annular groove 401 when aligned therewith. Ina similar manner, a plurality of tapered surfaces 228 may be formed onexterior portions of end 224 of drive shaft 222 extending from powereddriver 200 to radially expand detent mechanisms 421 and 422 radiallyoutward during the insertion of end 224 of powered driver 200 intosecond end 252 of coupler assembly 250. Detent mechanisms 421 and 422will “snap” into annular groove 402 when aligned therewith. See FIG. 5A.

Engagement between detent mechanisms associated with latch 410 withannular groove 401 of hub assembly 130 a will generally retain secondend 102 of biopsy needle 100 b securely engaged with first end 251 ofcoupler assembly 250. This engagement may allow powered driver 200 torotate or spin cannula or biopsy needle 110 while withdrawing cannula orbiopsy needle 110 from an insertion site. In a similar manner,engagement between detent mechanisms 421 and 422 of omega shaped latch420 and annular groove 402 of end 224 of powered driver 200 willgenerally retain second end 252 of coupler assembly 250 engaged withpowered driver 100 during withdrawal of cannula 110 b from an insertionsite.

IO needle set 100 may be released from first end 251 of coupler assembly250 by sliding first housing segment 280 longitudinally toward secondend 262 of elongated core 260. Such movement of first housing segment280 will result in interior tapered surface 286 contacting exteriorportions of omega shaped latch 410 and compressing omega shaped latch410 to radially expand associated detent mechanisms (not expresslyshown) from engagement with annular groove 401 of hub assembly 130 a. Asa result, IO needle set 100 may be easily withdrawn from first end 251of coupler assembly 250.

In a similar manner, longitudinal movement of second housing segment 290toward first end 251 of coupler assembly 250 will result in interiortapered surface 296 contacting exterior portions of omega shaped latch420 to compress generally omega shaped latch 420 and withdraw or retractdetent mechanisms 421 and 422 from engagement with annular groove 402 ofend 224. See FIG. 5B. As a result, powered driver 200 and second end 252of coupler assembly 250 may be easily disconnected from each other.

Coupler assemblies 250 and 250 a may have substantially the same overallconfiguration and dimensions including respective flange 254 extendingradially from second end 252 and 252 a. Flange 254 may be generallydescribed as having an enlarged funnel shaped or bell shapedconfiguration. The dimensions and configuration of flange 254 may beselected to be compatible with end 211 of powered driver 200. In someembodiments a coupler assembly 250 b may not have a respective flange254 (not expressly shown). Second end 272 b of housing assembly 270 bmay terminate proximate first end 262 of associated elongated core 260and associated second end 252 b of coupler assembly 250 b.

Further details about coupler assemblies and other latch mechanisms andrelease mechanisms may be found in co-pending U.S. patent applicationSer. No. 11/853,678, filed on Sep. 11, 2007 entitled “Apparatus AndMethods For Biopsy And Aspiration Of Bone Marrow” (now U.S. Pat. No.8,668,698).

FIG. 9 depicts an example of apparatus and methods which may be used toinsert a first end 111 of the generally hollow cannula or IO needle 100into the cortex of a bone and/or associated bone marrow. Skin and softtissue 302 generally cover insertion sites in crest 304 of the bone. Allbones generally include a tough, hard to penetrate layer of cortex 306.FIG. 9 shows enlarged skin and soft tissue layer 302 and cortex layer306 for illustration purposes only. A typical thickness for skin andsoft tissue layer 302 may be seven to eight millimeters (7 mm to 8 mm).A typical thickness for cortex layer 306 may be approximately twomillimeters (2 mm).

As previously discussed an intraosseous (IO) device or IO needle set 100may be inserted in the cortex of a bone with minimum trauma to deliver atherapeutic medicament and/or obtain bone and/or bone marrow samples inaccordance with teachings of the present disclosure.

The medical devices, medical procedure trays, kits and diagnosticmethods and therapeutic methods of the present disclosure may be used totreat or evaluate any bone, such as but not limited to, bones of thevertebrae, neck bones, sternum, rib, clavicle, femoral, pelvic, wristand the distal ends of the long bones. Some exemplary conditions thatmay be diagnosed or treated may include fractures, osteoporosis,degenerative bone diseases, bone cancers, metastatic bone disease,osteolytic bone disease, osteomalacia, osteitis fibrosa, Paget'sdisease, bone deficiency, hyperparathyroidism. Fractures or degenerationof bone may result from osteoporosis which may be age-relatedosteoporosis, post-menopausal osteoporosis, juvenile osteoporosis,Cushing's syndrome osteoporosis, multiple myeloma osteoporosis, leukemiaosteoporosis, Turner's syndrome osteoporosis, alcohol osteoporosis,chronic liver disease osteoporosis, glucocorticoid-induced osteoporosis,chronic inflammatory disease induced osteoporosis and disuseosteoporosis.

FIGS. 10A-10D depict an exemplary medical procedure performed on avertebral disc of a human patient using the methods, devices, medicalprocedure trays and kits of the disclosure. In a non-limiting example,the vertebral procedure may be vertebroplasty. The teachings of thepresent disclosure are however not limited to vertebroplasty orvertebral procedures and medicaments or therapeutic agents of any typemay be delivered to a vertebral bone (or any other bone) and/or abiological sample may be obtained for analysis during the sameprocedure.

In an example vertebroplasty procedure, depicted in FIGS. 10A-10D, anoperator may obtain a medical procedures tray 20 comprising a vertebralIO device as set forth in the present disclosure, comprising a vertebralIO needle system/set 100, power driver 200, coupler assembly 250comprising sterile sleeve 170. An example vertebral IO device maycomprise a vertebroplasty needle set and may include a beveled needlecomprising a cannula 100 a and a stylet with a beveled cutting tip and aserrated cutting edge (see FIGS. 7B and 7F). The IO device may alsocomprise a biopsy needle set, and may comprise a cannula 100 d with ahelical thread 192 for capturing a bone sample (see FIGS. 8A and 8B).The coupler assembly 250 may be operable to releasably attach differentvertebral IO needles 100 at end 251 and releasably attach power driver200 at end 252.

The operator may assemble the vertebral system apparatus by unwrapping asterile medical procedure tray and attaching a non-sterile power driver200 to end 252 of the coupler assembly 250 and covering power driver 250with sterile glove 170 as shown in FIGS. 3A and 3B. Sterile vertebralneedle 100 a may be then attached to end 251 of the coupler 250 as shownin FIG. 3C. The sterile vertebral needle 100 a attached to the vertebralapparatus as in FIG. 3C may then be inserted into a vertebral disc“powered in.” Generally, an operator trained to perform such aprocedure, may insert a vertebral needle 100 through the cortex 306 of avertebral bone into the vertebral body 307 using powered drill 200 underthe guidance of fluoroscopy or other visual imaging methods. Followingpowering in, driver 200 may be released from the coupler 250 and thestylet comprising a beveled cutting tip and/or a serrated cuttingsurface and/or any other suitable cutting tip may be withdrawn from thecannula 100 of the vertebral needle, thereby leaving the cannula 100firmly seated in the vertebral body 307 (see FIG. 10B).

A trocar, and/or needle, and/or ejector rod, and/or syringe filled witha bone cement 309 (and/or other medicaments) may be slidably disposedinto cannula 100 a as shown in FIG. 10C (trocar/needle/rod/syringe 100 bnot expressly shown) and bone cement 309 may be injected into thevertebral body 307. A connection (such as a Luer lock) may be used toattach 100 b with 100 a. The trocar 100 b may comprise one or moretherapeutic agents to be delivered into a bone such as a vertebral disc.For example, a bone strengthening agent/factor may be delivered with thebone cement. In some embodiments, the bone cement or therapeutic agentmay be delivered directly through the cannula 100 a into the vertebralbody (without requiring trocar 100 b). The injected bone cement willtypically solidify and strengthen a fractured and/or compressedvertebra.

Either preceding or following injection of the bone cement 309 into thevertebral body 307, a biopsy needle 100 d comprising handle 96, firstend 91 and second end 92 may be inserted into cannula 100 and used toobtain a specimen of bone tissue for diagnostic analysis (see FIG. 10D).The biopsy needle 100 d may then be withdrawn, power driver 200reattached to coupler assembly 250 at end 251 and the cannula 100 may bewithdrawn from the patient “powered out” (not expressly shown). Thus, atherapeutic procedure may be combined with a diagnostic procedure usingthe IO needles, IO devices, methods, kits and trays of the presentdisclosure.

Following the medical and/or diagnostic procedures, the driver 200 maybe detached from the coupler assembly and cleaned and stored for furtheruse. A non-sterile power driver 200 may be used with disposable needles100 and a disposable coupler 250, comprising a sterile sleeve 170,thereby allowing multiple use of the non-sterile power driver.

As described above, for delivery of a therapeutic agent to bone and/orfor removal of a biological specimen from a bone the needles 100 b or100 d as depicted in FIGS. 10A-10D may also be referred to as an“ejector rod”. An ejector rod, such as 100 b or 100 d, may be slidablydisposed into a hollow cannula 100 a of an IO needle to deliver amedicament or obtain a biological sample from a bone.

The length of ejector 100 b or 100 d may be selected to be greater thanthe length of a lumen in an associated IO needle 100 a. Handle or hub 96may be disposed on second end 92 of ejector 100 b or 100 d. Thedimensions and configuration of first end 91 of ejector rod 100 b or 100d may be selected to be compatible with inserting first end 91 throughan opening in the first end of an associated IO needle 100 a. As setforth above, the teachings of the present disclosure are not limited tovertebroplasty or vertebral procedures and medical procedures fordelivery of a therapeutic agent and possibly combining such atherapeutic procedure with a diagnostic procedure are provided by thisdisclosure for any bone and any bone related condition.

Benefits of the present disclosure may include reducing physicalrequirements and mental stress on operators and decreasing pain andstress on patients by increasing speed and control of the needle setinsertion during vertebral procedures or other bone procedures and bydecreasing the number of procedures performed and the number of times abone is drilled into.

Although the present disclosure and its advantages have been describedin detail, it should be understood that various changes, substitutionsand alternations can be made herein without departing from the spiritand scope of the invention as defined by the following claims.

What is claimed is:
 1. An intraosseous (IO) medical procedures traycomprising: at least one IO device comprising at least one set of IOneedles; the IO needle set comprising at least one IO needle operable topenetrate a bone and at least one IO needle operable to deliver atherapeutic agent to the bone; a coupler assembly comprising a first endoperable to releasably engage one or more IO devices and a second endoperable to releasably engage a powered driver; the coupler furthercomprising a sterile containment bag operable to enclose the powereddriver; slots and holders for each component; and a removable sterilecover over the IO medical procedures tray to maintain sterility of thecomponents.
 2. An intraosseous (IO) medical procedures tray of claim 1,further comprising other components for placement in the tray from thegroup consisting of a containers for sharps, a container for collectinga medical sample, an ejector funnel, and one or more smaller trayscomprising one or more components of the tray.
 3. An intraosseous (IO)medical procedures tray of claim 1, further comprising selecting IOdevices for placement in the tray from the group consisting of an IOneedle operable to penetrate any bone, a vertebral needle set, a biopsyneedle set, an aspiration needle set, a vertebral needle operable topenetrate a vertebral bone, a biopsy needle, an aspiration needle, atrocar operable to inject a therapeutic agent into a bone, an ejectorrod operable to inject a therapeutic agent into a bone, an ejectoroperable to remove a biopsy sample from a bone, a rod operable to removea biopsy sample from a vertebral bone, a rod operable to be slidablyinserted into a vertebral needle that is operable to penetrate avertebral bone, an IO needle operable to inject bone cement into a boneand combinations thereof.
 4. An intraosseous (IO) medical procedurestray of claim 1, wherein the IO needle set further comprises at leastone IO needle operable to obtain a medical sample from the bone.
 5. Anintraosseous (IO) medical procedures tray of claim 4, further comprisingother components for placement in the tray from the group consisting ofa containers for sharps, a container for collecting a medical sample, anejector funnel, and one or more smaller trays comprising one or morecomponents of the tray.
 6. An intraosseous (IO) medical procedures trayof claim 4, further comprising selecting IO devices for placement in thetray from the group consisting of an IO needle operable to penetrate anybone, a vertebral needle set, a biopsy needle set, an aspiration needleset, a vertebral needle operable to penetrate a vertebral bone, a biopsyneedle, an aspiration needle, a trocar operable to inject a therapeuticagent into a bone, an ejector rod operable to inject a therapeutic agentinto a bone, an ejector operable to remove a biopsy sample from a bone,a rod operable to remove a biopsy sample from a vertebral bone, a rodoperable to be slidably inserted into a vertebral needle that isoperable to penetrate a vertebral bone, an IO needle operable to injectbone cement into a bone and combinations thereof.
 7. A vertebral medicalprocedures tray comprising slots and holders for each component, thecomponents comprising: at least one vertebral IO device comprising atleast one vertebral IO needle set; the vertebral IO needle setcomprising at least one vertebral IO needle operable to penetrate avertebral bone and at least one IO needle operable to deliver atherapeutic agent to the vertebral bone or a vertebral body; a couplerassembly comprising a first end operable to releasably engage one ormore vertebral IO devices and a second end operable to releasably engagea non-sterile powered driver; the coupler further comprising a sterilecontainment bag operable to enclose the non-sterile powered driver; anda removable cover over the vertebral IO medical procedures tray tomaintain sterility of the components.
 8. A vertebral medical procedurestray of claim 7, wherein the at least one IO needle operable to delivera therapeutic agent to the vertebral bone or a vertebral body is an IOneedle operable to deliver bone cement into the vertebral bone or thevertebral body.
 9. A vertebral medical procedures tray of claim 7,further comprising a vertebral biopsy needle set comprising at least onebiopsy needle operable to obtain a medical sample from a vertebral body.10. A vertebral medical procedures tray of claim 7, further comprising avertebral aspiration needle set comprising at least one aspirationneedle operable to obtain a medical sample from a vertebral body.
 11. Avertebral medical procedures tray of claim 7, further comprisingselecting vertebral IO devices or other components for placement in thetray from the group consisting of a containers for sharps, a containerfor collecting a medical sample, an ejector funnel, and one or moresmaller trays comprising one or more components of the tray, a vertebralneedle set, a biopsy needle set, an aspiration needle set, a vertebralneedle operable to penetrate a vertebral bone, a biopsy needle, anaspiration needle, a trocar operable to inject a therapeutic agent intoa vertebral bone, an ejector rod operable to inject a therapeutic agentinto a vertebral bone, an ejector operable to remove a biopsy samplefrom a vertebral bone, a rod operable to remove a biopsy sample from avertebral bone, a rod operable to be slidably inserted into a vertebralneedle that is operable to penetrate a vertebral bone, an IO needleoperable to inject bone cement into a vertebral body and combinationsthereof.